Mask system comprising a combined air delivery and stabilizing structure

ABSTRACT

An air delivery system for providing a supply of air from a source of air at positive pressure to an interfacing structure located at the entrance to the airways of a patient includes a manifold adapted to connect with the supply of positive air pressure and at least one tube connected to the manifold and adapted to deliver the supply of air to the interfacing structure. Each tube is structured to allow movement between an open phase in which the tube allows the passage of air and a collapsed phase in which the tube is collapsed. Each tube is structured such that weight of a typical patient&#39;s head against bedding apparel is sufficient to collapse the tube from the open phase to the collapsed phase.

CROSS-REFERENCE TO APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/235,620 filed Dec. 28, 2018, which is a continuation of U.S. patentapplication Ser. No. 15/650,577 filed Jul. 14, 2017, which is acontinuation of U.S. patent application Ser. No. 12/085,191, filed Apr.16, 2009, which was the U.S. National Phase of International ApplicationNo. PCT/AU2007/001051, filed Jul. 27, 2007, which designated the U.S.and claimed the benefit of U.S. Provisional Application Nos. 60/833,841,filed Jul. 28, 2006, 60/874,968, filed Dec. 15, 2006, 60/924,241, filedMay 4, 2007, and 60/929,393, filed Jun. 25, 2007, each of which ishereby incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to the delivery of respiratory therapy to apatient. Examples of such therapies are Continuous Positive AirwayPressure (CPAP) treatment, Non-Invasive Positive Pressure Ventilation(NIPPV), and Variable Positive Airway Pressure (VPAP). The therapy isused for treatment of various respiratory conditions including SleepDisordered Breathing (SDB) and more particularly Obstructive Sleep Apnea(OSA).

BACKGROUND OF THE INVENTION

Typically, respiratory therapy is delivered in the form of a mask systempositioned between a patient and apparatus providing a supply ofpressurized air or breathing gas. Mask systems in the field of theinvention differ from mask systems used in other applications such asaviation and safety in particular because of their emphasis on comfort.This high level of comfort is desired because patients must sleepwearing the masks for hours, possibly every night for the rest of theirlives. In addition, therapy compliance can be improved if the patient'sbed partner is not adversely affected by the patient's therapy andwearing of the mask generally.

Mask systems typically have a highly clinical aesthetic (as will bedescribed below). This can lead to patients becoming embarrassed abouttheir therapy since the clinical aesthetic serves as a blatant reminderthat they are ill and consequently can leave a negative perception ofthe patient in the mind of an observer.

Mask systems typically, although not always, comprise (i) a rigid orsemi-rigid portion often referred to as a shell or frame, (ii) a soft,patient contacting portion often referred to as a cushion, and (iii)some form of headgear to hold the frame and cushion in position. If themask system does in fact include multiple components, at least someassembly and adjustment may be required, which can be difficult forpatients who may suffer from lack of dexterity, etc. Further, masksystems often include a mechanism for connecting an air deliveryconduit. The air delivery conduit is usually connected to a blower orflow generator.

Patient contacting portions, e.g., cushions, are typically constructedof a silicone material, but patient contacting portions including foamare known. For example, U.S. Pat. No. 5,429,683 discloses a lining for amask made of a polyurethane foam covered with skin (e.g., latex orsilicone). However, skinned foam does not allow the portion in contactwith the face to breathe, which can lead to skin irritation, and thesealing portion may be subject to creasing which may cause discomfortand lead to leak. The skin can also feel too hard for some patients,depending on the thickness and support structure. The skin also does notallow a high degree of local deformation and may be subject to tensiontransfer across its surface, which can result in shifting of the mask onthe face and loss of seal/comfort.

A range of mask systems are known including nasal masks, nose & mouthmasks, full face masks and nasal prongs, pillows, nozzles & cannulae.Masks typically cover more of the face than nasal prongs, pillows,nozzles and cannulae. Nasal prongs, nasal pillows, nozzles and cannulaeall will be collectively referred to as nasal prongs.

There is a continuous need in the art to provide mask systems with ahigh level of comfort and usability and a newly perceived need toprovide mask systems having improved aesthetics (i.e., less clinical andbulky).

SUMMARY OF THE INVENTION

One aspect of the present invention is to provide a therapycompliance-enhancing patient interface.

Another aspect of the present invention is to provide a comfortablepatient interface.

Another aspect of the invention is to provide a patient interface havinga non-medical appearance. In one form, this may be achieved by creatinga soft, comfortable, flexible patient interface that has the appearanceof an article of clothing.

Another aspect of the invention relates to a comfortable, unobtrusive,easy to use, stable system for delivering a supply of air at positivepressure to the entrance to the patient's airways such as may be used innasal CPAP treatment of sleep disordered breathing. This system iscompatible with a range of interfaces and/or sealing structures,including nasal masks, nasal cushions, mouth masks, etc. The system hasbeen particularly designed so that a patient may comfortably sleep in arange of different positions, including rolling onto the side of theirface, without experiencing discomfort and while maintaining adequatetherapy. This system offers a number of improvements over the prior art.

Another aspect of the invention relates to an interfacing structure thatprovides improved comfort, enhanced interfacing performance, and ease ofuse over prior sealing structures. Aspects of the improved interfacingstructure are that it requires less precise fitting than prior sealingstructures and does so with a more comfortable and even pressuredistribution on the patient's face. The interfacing structure has a morenatural feel against the skin than prior sealing structures and alsofeatures controlled air permeability so that the skin is allowed tobreathe. Another aspect of the improved interfacing structure is that itis less prone to disruption by movement than prior sealing structures.

Another aspect of the invention relates to an air delivery system forproviding a supply of air from a source of air at positive pressure toan interfacing structure located at the entrance to the airways of apatient. The air delivery system includes a manifold adapted to beconnected with the supply of positive air pressure and at least one tubeconnected to the manifold and is adapted to deliver the supply of air tothe interfacing structure. Each tube is structured to allow movementbetween (1) an open phase in which the tube allows the passage of airand (2) a collapsed phase in which the tube is collapsed. Each tube isstructured such that weight of a typical patient's head against beddingapparel (e.g., pillow) is sufficient to collapse the tube from the openphase to the collapsed phase.

Another aspect of the invention relates to an air conduit or tube thatis comfortable to lie on because: when you lie on the conduit, the partthat you lie on squashes flat or substantially flat; the conduit isgenerally sufficiently thin so that you can lie on it; and/or theconduit does not need to flatten because it is already sufficientlycomfortable.

Another aspect of the invention relates to a system of air conduitshaving sufficient redundancy that if some or one of the conduits isoccluded, the system retains sufficient flow of air at therapeuticpressure.

Another aspect of the invention relates to an air delivery systemadapted to provide a therapeutic supply of air at pressure when aportion is being lain on by the patient.

Another aspect of the invention relates to an air delivery system forproviding a supply of air from a source of air at positive pressure toan interfacing structure located at the entrance to the airways of apatient. The air delivery system includes a manifold adapted to connectwith the supply of positive air pressure and at least one tube connectedto the manifold, the tube being adapted to deliver the supply of air tothe interfacing structure. The manifold is adapted to be positioned onor in front of a crown of the patient's head in use.

Another aspect of the invention relates to an air delivery andstabilizing system for providing a supply of air from a source of air atpositive pressure to an interfacing structure located at the entrance tothe airways of a patient. The air delivery system includes a manifoldadapted to connect with the supply of positive air pressure, a pair oftubes connected to the manifold and adapted to deliver the supply of airto the interfacing structure, a rigidizing element provided to each tubeto add rigidity to the tube, and a back strap provided to the tubesand/or rigidizing elements and adapted to engage the back of thepatient's head. Each tube is adapted to extend from a respective side ofthe manifold at or in front of the crown of the patient's head, along arespective side of the patient's face between the patient's eye and ear,and under the patient's nose.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient including a supportstructure adapted to be coupled to an air delivery system that providesa supply of air from a source of air at positive pressure and aninterface provided to the support structure. The interface isconstructed of a soft viscoelastic foam and adapted to contact withsurfaces of the patient's face and nose in use.

Another aspect of the invention relates to a patient interface includinga first loop and a second loop connected to the first loop. The firstloop is adapted to pass along an underside of the patient's nose, alongthe cheek region, above the ears, and over the crown of the patient'shead to define a sealing force against the underside of the patient'snose in use. The second loop is adapted to pass generally over theoccipital bone to define a headgear vector at an angle between 40°-80°with the first loop.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface adapted to contact with skin surfacesunder the patient's nose in use, wherein the interface has a thicknessof about 5-50 mm.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface adapted to contact with skin surfacesunder the patient's nose in use, wherein the interface includes anunskinned surface on surfaces for interfacing or contacting thepatient's skin in use.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface adapted to contact with skin surfacesunder the patient's nose in use, wherein the interface includessufficient softness and compliance in a direction normal to thepatient's face to conform to the facial anatomy that it is interfacingwith.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface adapted to contact with skin surfacesunder the patient's nose in use, wherein the interface is constructed ofbreathable or permeable material.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface constructed of foam and adapted tocontact with skin surfaces under the patient's nose in use, wherein theinterface is adapted to provide a compressive force to seal against thepatient's skin in use.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface adapted to contact with skin surfacesunder the patient's nose in use, wherein the interface has a texturedsurface.

Another aspect of the invention relates to an interfacing structurelocated at an entrance to the airways of a patient. The interfacingstructure includes an interface adapted to contact with skin surfacesunder the patient's nose in use, wherein the interface includes a rateof return of less than about 5 cm/sec.

Another aspect of the invention relates to an air delivery system forproviding a supply of air from a source of air at positive pressure to apatient. The air delivery system includes an interfacing structurelocated at the entrance to the airways of the patient and a pair oftubes adapted to extend along a respective side of the patient's faceand deliver the supply of air to the interfacing structure. Each tubehas at least one portion that is structured to allow movement between(1) an open phase in which the tube allows the flow of air without undueresistance and (2) at least a partially collapsed phase in which thetube is at least partially collapsed to restrict or prevent the flow ofair. Each tube is structured such that it is comfortable to lie on.

Another aspect relates to a gas delivery system for providing a supplyof gas from a source of gas at positive pressure to an interfacingstructure located at an entrance to the airways of a patient. The gasdelivery system includes at least two gas passages adapted to be incommunication with the source of gas to deliver the supply of gas to theinterfacing structure. The at least two gas passages are structured andconfigured to cooperate such that an adequate supply of gas is deliveredto the interfacing structure even if one of the gas passages assumes acollapsed configuration to prevent or substantially impede the flow ofair.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of variousembodiments of this invention. In such drawings:

FIGS. 1-1 to 1-16 are various views of a patient interface according toan embodiment of the present invention;

FIGS. 2-1 to 2-2 are schematic views illustrating assembly of a patientinterface according to an embodiment of the present invention;

FIG. 2-3 is a schematic view illustrating attachment of a patientinterface to a PAP device according to an embodiment of the presentinvention;

FIGS. 2-4 a to 2-4 b illustrate attachment of a patient interface to aPAP device according to another embodiment of the present invention;

FIGS. 3-1, 3-2 a, and 3-2 b illustrate a tube of a patient interface inopen and collapsed phases according to an embodiment of the presentinvention;

FIG. 3-3 is a schematic view of a tube and rigidizing element of apatient interface according to an embodiment of the present invention;

FIGS. 3-4 and 3-4 a to 3-4 f illustrate various cross-sections of a tubealong its length according to an embodiment of the present invention;

FIGS. 3-5 a to 3-5 c are schematic views of a tube of a patientinterface in open and collapsed or partially collapsed phases accordingto another embodiment of the present invention;

FIGS. 3-6 a to 3-6 b illustrate a tube having a concertina configurationaccording to another embodiment of the present invention;

FIGS. 4-1 to 4-5 illustrate tubing for a patient interface according toan embodiment of the present invention;

FIGS. 4-6 to 4-9 illustrate tubes and a rigidizing element according toan embodiment of the present invention;

FIGS. 5-1 to 5-3 illustrate tubes of a patient interface according toalternative embodiments of the present invention;

FIGS. 6-1 to 6-4 illustrate a back strap of a patient interfaceaccording to an embodiment of the present invention;

FIG. 6-5 illustrates a back strap of a patient interface according toanother embodiment of the present invention;

FIGS. 7-1 to 7-2 illustrate manifolds of a patient interface accordingto alternative embodiments of the present invention;

FIGS. 8-1 to 8-5 illustrate a tube configuration according to anembodiment of the present invention;

FIG. 8-6 is a schematic view that illustrates a region where tubing maypass according to an embodiment of the present invention;

FIG. 8-7 illustrates an adjustable tube configuration according toanother embodiment of the present invention;

FIGS. 9-1 to 9-3 illustrate a method for fitting a patient interfaceaccording to an embodiment of the present invention;

FIGS. 10-1 to 10-6 are various views of a patient interface including acover according to an embodiment of the present invention;

FIG. 11-1 illustrates a valve of a patient interface according to anembodiment of the present invention;

FIGS. 12-1 to 12-3 illustrate clips of a patient interface according toalternative embodiments of the present invention;

FIGS. 13-1 to 13-2 are various views of a foam interface and supportaccording to an embodiment of the present invention;

FIGS. 13-3 and 13-4 are top and side views of a foam interface having acut, unskinned surface according to an embodiment of the presentinvention;

FIG. 13-5 is a top view of a foam interface having a skinned surfaceaccording to an embodiment of the present invention;

FIG. 13-6 is an enlarged, schematic cross-section of a portion of thefoam interface shown in FIG. 13-5;

FIGS. 13-7 a to 13-7 c illustrate foams according to alternativeembodiments of the present invention;

FIG. 13-8 is a schematic cross-section of a portion of a foam interfacehaving a skinned surface and a vent according to an embodiment of thepresent invention;

FIG. 14-1 is a table of mechanical properties of a foam interfaceaccording to an embodiment of the present invention;

FIG. 14-2 is a graph illustrating properties of a foam interfaceaccording to an embodiment of the present invention;

FIG. 14-3 is a schematic view of a dispenser adapted to dispenseindividual packages containing a foam interface according to anembodiment of the present invention;

FIGS. 15-1 to 15-2 illustrate front and side cross-sectional views,respectively, of a foam interface according to an embodiment of thepresent invention;

FIG. 16-1 is a schematic view of a patient interface according to anembodiment of the present invention;

FIGS. 16-2 to 16-3 are schematic views of a frame and force vectoraccording to an embodiment of the present invention;

FIG. 17-1 schematically illustrates layers of an interfacing structureaccording to an embodiment of the present invention;

FIG. 17-2 illustrates a method of joining an interface to a frameaccording to an embodiment of the present invention;

FIGS. 17-3A to 17-3C illustrate a mechanical interference typeattachment mechanism to removably attach an interfacing structure to apatient interface according to an embodiment of the present invention;

FIGS. 17-4A to 17-4C illustrate a hook and loop type attachmentmechanism to removably attach an interfacing structure to a patientinterface according to an embodiment of the present invention;

FIGS. 18-1 to 18-3 illustrate a method of joining an under-the-noseinterface to a frame according to an embodiment of the presentinvention;

FIGS. 19-1 to 19-3 are sequential views illustrating a manufacturingprocess for applying a pressure sensitive adhesive to the back of anunder-the-nose interface according to an embodiment of the presentinvention;

FIGS. 20-1 to 20-3 illustrate a method of joining an under-the-noseinterface to a frame according to an embodiment of the presentinvention;

FIGS. 20-4 to 20-7 are sequential views illustrating a manufacturingprocess for forming a composite under-the-nose interface according to anembodiment of the present invention;

FIGS. 21-1 to 21-3 illustrate a flexible frame according to anembodiment of the present invention;

FIG. 22-1 illustrate a flexible frame according to another embodiment ofthe present invention;

FIG. 23-1 illustrates a flexible frame with a spring element accordingto an embodiment of the present invention;

FIG. 23-2 is a graph for a variable spring element with k values thatvary across its length according to an embodiment of the presentinvention;

FIG. 23-3 illustrates a flexible frame with a spring element accordingto another embodiment of the present invention;

FIG. 24-1 illustrates a foam interface including a rigidizer thatprovides venting according to an embodiment of the present invention;

FIG. 25-1 illustrates a patient interface including an under-the-noseinterface and a mouth interface according to an embodiment of thepresent invention;

FIG. 26-1 is a perspective view of a known mask commercially sold byRespironics under the name of ComfortCurve™;

FIGS. 26-2 to 26-10 illustrate improvements and/or alternativearrangements of Respironics' ComfortCurve™ mask according to embodimentsof the present invention;

FIG. 27-1 is a perspective view of a known mask commercially sold byRespironics under the name of OptiLife™;

FIGS. 27-2 to 27-7 illustrate improvements and/or alternativearrangements of Respironics' OptiLife™ mask according to embodiments ofthe present invention;

FIG. 28-1A is a perspective view of a known mask commercially sold byRespironics' under the name of ComfortLite™;

FIG. 28-2A illustrates an improvement and/or alternative arrangement ofRespironics' ComfortLite™ mask according to an embodiment of the presentinvention;

FIG. 28-1B is a perspective view of a known mask commercially sold byRespironics' under the name of ComfortLite™ 2;

FIG. 28-2B illustrates an improvement and/or alternative arrangement ofRespironics' ComfortLite™ 2 mask according to an embodiment of thepresent invention;

FIGS. 29-1 to 29-2 illustrate a known mask commercially sold by Fisher &Paykel under the name of Opus™;

FIGS. 29-3 to 29-9 illustrate improvements and/or alternativearrangements of Fisher & Paykel's Opus™ mask according to embodiments ofthe present invention;

FIGS. 30-1 to 30-2 are perspective views of a known mask commerciallysold by Puritan Bennett under the name of Breeze® SleepGear® DreamSeal®;

FIGS. 30-3 to 30-5 illustrate improvements and/or alternativearrangements of Puritan Bennett's Breeze® SleepGear® DreamSeal® maskaccording to embodiments of the present invention;

FIGS. 31-1 to 31-2 illustrate a known mask commercially sold by InnoMedTechnologies under the name of Nasal-Aire™; and

FIGS. 31-3 to 31-4 illustrate improvements and/or alternativearrangements of InnoMed Technologies' Nasal-Aire™ mask according toembodiments of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

While the patient interfaces below are described as includingunder-the-nose interface types, the patient interfaces may be adaptedfor use with other suitable interface types. That is, the interface typeis merely exemplary, and aspects of the present invention may be adaptedto include other interface types, e.g., nasal cushions, nasal prongs,full-face masks, mouth masks, etc.

Embodiments of the invention are directed towards moving fromuncomfortable, unattractive mask systems to sleek and elegant patientinterfaces that are soft, comfortable, lightweight, functional, therapyenhancing, fashionable, easy and intuitive to fit and adjust with littleor no adjustment, shape holding, low impact, low profile, continuity ofform, individualized or customized, and/or are more appealing and muchless objectionable by patients and bed partners alike. The subjectpatient interfaces are less obstructive, less obtrusive, anatomicallycoherent and appear like an organic extension of and/or blends with thepatient, rather than a bulky, mechanical extension affixed to thepatient which can appear to be ungainly or unattractive. This can helpthe patient and the patient's bed partner more readily relax and/orsleep during treatment. Moreover, the patient interface can improve theoverall perception such that the patient is simply wearing a garmentlike a night cap or bed clothes, etc. rather than being treated for arespiratory illness. This improved perception can help increase thechances that the patient will actually wear the patient interface andcomply or better comply with therapy, therefore increasing thelikelihood of effective therapy for the user of the device. There isalso the possibility that the bed partner will more readily accept andparticipate in the patient's therapy by encouraging the use of asleep-enhancing device that is easy to use/adjust, more attractiveand/or appealing interface.

Patient Interface

FIGS. 1-1 to 1-16 illustrate a patient interface or mask system 10according to an embodiment of the present invention. As illustrated, thepatient interface 10 includes an interfacing structure 20 (also referredto as a cushioning structure or conforming structure) adapted to providean effective interface with the patient's face and an air delivery andstabilizing system 30 (also referred to as conduit headgear or inletconduit arrangement) adapted to deliver breathable gas to theinterfacing structure 20 and support the patient interface 10 in adesired position on the patient's head. A cover (also referred to as asock or covering) may be optionally provided to substantially encloseone or more portions of the interfacing structure 20 and/or the airdelivery and stabilizing system 30.

1. Air Delivery and Stabilizing System

1.1 Background and Summary

Known patient interfaces typically include separate headgear and airdelivery components that are used to locate and supply breathable gas toa mask or the like. Known headgear typically includes an assembly ofelastic (or inelastic) straps, buckles, locks, and/or clips. Known airdelivery components typically include 15-22 mm diameter spiralreinforced tubing and swivel connectors. These known arrangements ofheadgear and air delivery components can be difficult to use for thosewho are less dexterous and/or unfamiliar with them. These knownarrangements of headgear and air delivery components can also beuncomfortable or impractical to lie on.

One aspect of the present invention relates to air delivery andinterfacing structure stability provided by one combined system. In theillustrated embodiment, the air delivery and stabilizing system 30includes four main components, i.e., tubing 40, a rigidizer 50, a backstrap 60, and a manifold 70 (e.g., see FIG. 1-6). In use, a supply ofair is directed to the manifold 70, e.g., located on or in front of thecrown of the patient's head. The supply of air passes from the manifold70 to the tubing 50, e.g., at least one and preferably two tubes,towards the patient's nose and/or mouth. The tubing 40 has the propertyof being collapsible to lie on, yet sufficiently rigid in otherdirections so as to maintain sufficient stability of the interface.

1.2 Tubing

In the illustrated embodiment, the tubing 40 includes two tubes or inletconduits 42 (also referred to as gas passages or gas conduits)communicated with the interfacing structure 20 to deliver breathable gasto the interfacing structure 20 (e.g., see FIG. 1-6). In one embodiment,a single tube may be used. However, it is preferred that two tubes beused, so that a sufficient supply of breathable gas can still bedelivered to the interfacing structure 20 when one of the tubes 42 isfully collapsed, e.g., due to the patient lying on his/her side. Thatis, when two tubes 42 are used, one or both of the tubes 42 may be openin use. In an alternative embodiment, more than two tubes may be used,e.g., three or more tubes. For example, the tubing may provide a fourtube arrangement including two upper tubes along upper sides of thepatient's face and two lower tubes along lower sides of the patient'sface.

Each tube 42 includes a first end 42.1 adapted to engage a respectiveend of a frame 22 of the interfacing structure 20 and second end 42.2adapted to engage a respective end of the manifold 70, as shown in FIGS.2-1 and 2-2. In an embodiment, the frame 22 and manifold 70 may eachinclude tube portions 25 adapted to engage respective ends of the tubes42, e.g., via friction fit. In use, the tubes 42 are supplied withpressurized breathable gas from the manifold 70, and the pressurizedbreathable gas is delivered into opposing ends of the interfacingstructure 20.

In the illustrated embodiment, the tube portions 25 of the frame 22 andmanifold 70 (e.g., see FIGS. 2-1 and 2-2) each have a steppedconfiguration so that when the respective tube is attached thereto thejoint has a smooth, almost seamless form, e.g., no visible step changesin the overall form. For example, the boundary between each tube portion25 and the main body of the frame or manifold may have a step heightsubstantially equal to the wall thickness of the respective end 42.1,42.2 of the tube, and mating the tube portion and respective end of thetube will result in a smooth, almost seamless form at the joint. Thesmooth joint improves aesthetics and may have a functional benefit inreducing drag forces picked up on pillows, bedclothes, etc. as thepatient rolls around in bed in use.

In an alternative embodiment, the two tubes may be independentlyconnected to the supply of gas (e.g., positive airway pressure (PAP)device or flow generator). For example, as schematically shown in FIG.2-3, one tube 42 may extend from one end of the interfacing structure 20to a first outlet O1 of the PAP device and the other tube 42 may extendfrom the other end of the interfacing structure 20 to a second outlet O2of the PAP device. In such an arrangement, the manifold may beeliminated or the manifold may be incorporated into the PAP deviceitself.

In another embodiment, the two tubes may be joined together at an outletof the PAP device (e.g., both tubes adapted to be coupled to a singleoutlet of the PAP device), and then the tubes bifurcate (i.e., split ordivide into separated tubes) towards the interfacing structure. Forexample, as shown in FIG. 2-4 a, tube 42(1) may be coupled to a singleoutlet O of the PAP device and then split into separate tubes 42(2)towards respective ends of the interfacing structure 20. As shown inFIG. 2-4 b, the tube 42(1) may include an internal dividing wall W todivide the tube into two conduits associated with a respective one ofthe tubes 42(2).

1.2.1 Collapsible and Thin

In the illustrated embodiment, each tube 42 is structured such that itmay move between two phases, i.e., a first open phase in which the tube42 allows the passage of air (e.g., see FIG. 3-1) and a second collapsedphase in which the tube 42 is fully collapsed and comfortable to lie on(e.g., see FIG. 3-2 b). Each tube 42 is structured such that the weightof any patient's head (e.g., adult or infant/child) resting on the tube42 is sufficient to collapse the tube 42 so the patient may comfortablylie on his/her side (e.g., see FIGS. 1-3, 1-5, and 1-14). However,because the tubes have a consistency similar to that of a tubularballoon inflated under low pressure, each tube 42 may collapse undermuch less weight than a typical patient's head.

In the open phase, the tube is open or at least partially open so thatthe tube allows the passage of air, e.g., without undue resistance toflow, sufficient to provide treatment. In the collapsed phase, the tubeis collapsed to substantially prevent the passage or conductance of air.

It should be appreciated that each tube need not collapse fully orentirely to provide improved comfort. For example, each tube may bestructured such that it may move between a first open phase in which thetube 42 allows the passage of air and a second partially orsubstantially collapsed phase (e.g., see FIG. 3-2 a) in which the tube42 is at least partially or substantially collapsed to restrict and/orat least partially prevent the passage of air.

In a partially or substantially collapsed phase, opposing inner walls ofthe tube may engage one another at one or more points or surfaces alongtheir length such that conductance through the partially orsubstantially collapsed tube is minimized or even reduced to negligibleamounts. Also, in the partially or substantially collapsed phase, thetube may be open enough to maintain a small degree of conductance ofpressurized gas. A small degree of patency can be accomplished usingwall thicknesses of a certain gauge (such that opposed walls will notcontact or fully contact one another upon application of loads normallyencountered during therapy) and/or one or more short anti-crush ribsprovided to an inside surface of the tube.

Each tube 42 is sufficiently air tight and structured to deliver airfrom the top of the patient's head to the patient's nose withoutdiscomfort to the patient, e.g., see FIGS. 1-4 and 4-2. Impedanceprovided by the tube will be appropriate for the blower in use,regardless of whether one or both tubes are in the open phase. That is,the tube 42 provides a wide open cross-section with low impedance whenin the open phase and provides a low profile when in the collapsedphase. Moreover, the tubes essentially provide a linear tubing systemwith a parallel line which can be switched on or off (i.e., open phaseor collapsed phase), and the switching of either side of the parallelline off will have negligible effect on the total impedance of thetubing system. That is, the impedance “felt” by the PAP device issubstantially independent of whether one or both tubes are open. Thetubes may also be adapted to control pressure swings, e.g., deep breathby the patient.

In an embodiment, each tube 42 may have sufficient strength to maintainpatency or an open, unblocked state without being pressurized. That is,the tube 42 may be structured such that it only collapses when it is“actively” compressed, otherwise the tube 42 remains in its open phase.In an alternative embodiment, the supply of gas may help to inflate eachtube.

Each tube 42 may collapse anywhere along its length and may collapse toa substantially flat configuration so the tube 42 is substantially flatagainst the patient's face for comfort. However, the tube 42 may bestructured to collapse along selected portions thereof, e.g., middleonly, central only, etc.

In another embodiment, at least one tube may have at least one laterallyballooning feature. In such a tube (also referred to as a “bubble”tube), a portion of the tube is collapsed or partially collapsed and aportion of the tube is open, e.g., the tube is “pinched” in the middleto provide a general figure-8 shape. In another embodiment, at least onetube may have a relatively wide, flat shape to provide a stretched-outtube adapted to cover more of the patient's cheeks. For example, FIG.3-5 a is a schematic view of a tube 142 in its initial configuration,FIG. 3-5 b illustrates the tube 142 when end portions 144, 146 arecollapsed or partially collapsed into a flat configuration, and FIG. 3-5c illustrates the tube 142 when a middle portion 145 is collapsed orpartially collapsed into a flat configuration. In yet another variant,the tube could be preformed to have one or more relatively flatterportions 144, 145, 146 and one or more rounded conduit portions 147 asshown in FIGS. 3-5 b and 3-5 c.

It should be appreciated that the patient interface preferably does notcollapse at the manifold and in an area at the front of the patient'snose, e.g., at the interfacing structure 20. That is, the manifold maybe constructed of a substantially rigid material and the interfacingstructure 20 may include a substantially rigid frame (e.g., frame 22shown in FIG. 2-1) that prevents collapse in use. This arrangementensures that an air flow path is provided from at least one of the tubes42 to the patient's nose.

In an embodiment, each tube 42 may be molded from a silicone material,e.g., liquid silicone rubber (LSR), having a thin wall thickness ofabout 0.5 mm. However, each tube may have a wall thickness in the rangeof about 0.3 mm to 5 mm. The tubes may have varying colors, and thetubes may be formed in a mold with a polished surface to provide thetubes with smooth exterior surfaces. However, each tube may beconstructed from other soft, flexible materials, e.g., thermoplasticelastomers (e.g., Santoprene), foam, foam laminate, closed cellimpermeable foam, dipped and knitted textiles including cotton or silk.In an embodiment, each tube may be constructed from two sheets ofmaterial, e.g., laminate, that are attached to one another, e.g., heatwelded, to form a tube. In an alternative embodiment, each tube may beconstructed of a plurality of elements, e.g., relatively rigid elements,arranged in a concertina configuration so as to allow the tube to movebetween open and collapsed phases. In an embodiment, each tube may havea concertina configuration that allows each tube to collapse from onevolume to another smaller volume. For example, FIG. 3-6 a illustrates across-section of a concertina-type tube 542 in a first phase thatprovides a first volume, and FIG. 3-6 b illustrates the concertina-typetube 542 in a second phase that provides a second volume smaller thanthe first volume. In this example, one side 543 of the tube 542 isplaced adjacent the patient's face.

The tube arrangement according to an embodiment of the present inventioncontrasts with prior arrangements such as InnoMed's Nasal Aire and otherforms of nasal cannula that are designed to resist crushing (i.e.,breathable gas is able to be delivered through both tubes all the time)and thus present an uncomfortable structure for a patient to lie on.Furthermore, unlike prior arrangements, the tube arrangements accordingto embodiments of the present invention are capable of providing asufficient supply of pressurized gas when one of the pair of tubes isfully collapsed. Because of the particular arrangement of the pair oftubes in accordance with an embodiment of the present invention, bothtubes are not crushed at one time during normal use. This allows thepatient to assume any sleeping position (e.g., total freedom of sleepingposition) without compromising the supply of pressurized gas (e.g., seeFIGS. 1-1, 1-3, 1-5, 1-7, 1-8, and 1-14). That is, the tube arrangementaccording to an embodiment of the present invention provides two or moretubes that cooperate to maintain sufficient conductance of gas (e.g.,sufficient flow of gas at therapeutic pressure) and comfort to thepatient without introducing unnecessarily high impedance. For example,when a two tube arrangement is provided, each tube has sufficiently lowimpedance (e.g., large enough hydraulic diameter) which facilitates theadequate supply of gas when one of the tubes is occluded, e.g., lain on.

1.2.2 Cross-Sectional Profile

In the illustrated embodiment, each tube 42 has a non-cylindricalcross-sectional shape which provides a blending contour to blend withthe patient's face (e.g., see FIGS. 3-1 and 4-1 to 4-5). That is, eachtube 42 provides a blending contour or free form with few or no sharpedges or straight lines. The blending contour is smooth, streamlined,sleek, and blends or tapers the tubes 42 with or into the contours ofthe patient's head, e.g., anatomically coherent, less obtrusive and moreaesthetically appealing. In addition, the blending contour has no sharpedges that could cause discomfort, e.g., skin irritations or abrasions.

The contour or cross-section of each tube 42 may vary along its length,e.g., vary non-uniformly with location around the patient's head. In anembodiment, each tube may have a cross-sectional area that changes alongits length with an approximately constant hydraulic diameter. Forexample, each tube 42 may provide flatter regions in certain areas,e.g., where the patient rests on the tube during sleep. In this way, thetubes can be said to be an organic extension of the patient's facialcontours.

FIG. 3-1 illustrates an exemplary cross-section of a tube 42. Asillustrated, the tube 42 has a generally D-shaped cross-section andincludes an internal or inwardly facing surface 44 and an external oroutwardly facing surface 45.

The internal surface 44 is relatively flat and adapted to sitsubstantially flush against the patient's face in use. The internalsurface 44 may have a tapered configuration form an inner edge to anouter edge to provide a comfortable fit for a wide range of patients.The internal surface 44 provides a relatively large surface area whichresults in a more even load distribution. This arrangement is lesslikely to create pressure points in use. Also, the internal surface 44may have grip-like material to help stabilize the patient interface onthe patient's face. As described below, a rigidizing element may beprovided to the internal surface to add rigidity to the tube.

The external surface 45 has a smooth contour that blends with thepatient's face. That is, the external surface 45 has a profile ororganic form with edges that blend into the patient's face, e.g., in atangential manner, to prevent any edges from catching on bedclothes,pillows, etc., during sleep (e.g., when the patient rolls over).

As noted above, the generally D-shaped cross-section may vary along itslength, e.g., tall, thin D-shaped cross-section near the patient's noseand wide, shallow D-shaped cross-section along cheek and near the top ofthe patient's head. For example, FIGS. 3-4 and 3-4 a to 3-4 f illustratevarious cross-sections of a tube 42 along its length according to anembodiment of the present invention. Specifically, FIG. 3-4 aillustrates a cross-section of the tube 42 at the end adapted to engagethe manifold 70, FIG. 3-4 b illustrates a cross-section of the tube 42that is 20% of the tube length from the manifold end, FIG. 3-4 cillustrates a cross-section of the tube 42 that is 40% of the tubelength from the manifold end, FIG. 3-4 d illustrates a cross-section ofthe tube 42 that is 60% of the tube length from the manifold end, FIG.3-4 e illustrates a cross-section of the tube 42 that is 80% of the tubelength from the manifold end, and FIG. 3-4 f illustrates a cross-sectionof the tube 42 at the end adapted to engage the interfacing structure20. As illustrated, the D-shape of the cross-section varies along itslength. Specifically, each cross-section has a width w and a height h,and the width and height of the various cross-sections varies along thelength of the tube, e.g., a relatively long width and short height atthe manifold end and a relatively short width and tall height at theinterfacing structure end. Also, all of the cross-sections have a verysimilar or common hydraulic diameter, e.g., about 10-15 mm or about 13mm. The shape may be configured based on aesthetic and/or impedancerequirements. In addition, the shape may be configured to provide lowprofile, comfort, and/or stabilization.

However, the tubes 42 may have other suitable cross-sectional shapes,e.g., trapezoidal, semi-circular, cylindrical, oval, elliptical, flattersection, etc. Also, the tubes may have a flat configuration withanti-crush ribs. This arrangement is disclosed in U.S. patent Ser. No.10/385,701, the entirety of which is incorporated herein by reference.

FIGS. 5-1 to 5-3 illustrate alternative cross-sections of the tube. FIG.5-1 illustrates a tube 242 that more gradually blends into the patient'sface. As shown in FIG. 5-2, the tube 342 may provide a gap 343 in theinternal surface, e.g., to allow air flow or breathing. While lesspreferred than the cross-sections shown in FIGS. 3-1, 5-1, and 5-2, thecross-section of tube 442 in FIG. 5-3 would be more preferable than anormal cylindrical tube for its blending contour.

It is noted that a D-shaped or generally trapezoidal-shaped tube doesnot produce as pronounced pressure regions along bottom edges thereof asa semi-circular-shaped tube would. The reason for this is that the sidewalls of the D-shaped or generally trapezoidal-shaped tube meet the baseat an acute angle α, i.e., less than 90°, as shown in FIG. 3-1. The sidewalls of the semi-circular-shaped tube meet the base at approximately90°, and if the tube were pressed against the patient's face, the regionwhere the side walls meet the base would be quite rigid and may lead topressure points. In addition, a semi-circular-shaped tube may provide adiscontinuity of form when viewed in relation to the patient's facialcontours.

1.3 Air Delivery Rigidizing Element

In the illustrated embodiment, a rigidizing element or rigidizer 50 isprovided to each tube 42 to add rigidity to the tube 42 (e.g., see FIGS.1-6, 3-3, and 4-3 to 4-5). A rigidizing element 50 in accordance with anembodiment of the present invention is preferably thin and conformingwhen a patient lies upon it, yet has sufficient stiffness to resistout-of-plane bending. That is, the rigidizing element 50 is structuredto allow bending in some planes and resist bending in other planes,e.g., allow bending towards and away from the patient's face. Therigidizing element 50 also makes the tube 42 inextensible or notstretchy so that the tube 42 is strong in tension and maintains itssize.

In an embodiment, the rigidizing element 50 may provide structuralintegrity or self-holding form to the patient interface 10 so that thepatient interface 10 can hold its shape and not fall into a heap, e.g.,shape memory, whether the patient interface 10 is on or off thepatient's head. The shape holding arrangement maintains the tubes in adesired position and may facilitate donning of the patient interface inuse.

The rigidizing element 50 may be provided to an interior and/or exteriorportion of the tube 42. For example, FIGS. 1-6 and 4-1 to 4-5 illustratea rigidizing element 50 provided to an exterior portion of the tube 42(e.g., along internal surface 44) that is adapted to engage thepatient's head in use. As illustrated, the rigidizing element 50 mayinclude tubular end portions 52 to facilitate connection of the tubes 42to the manifold 70 and/or interfacing structure 20. The tube/rigidizersub-assembly may also provide an extension 53 for supporting the backstrap 60, e.g., see FIGS. 4-1, 4-2, and 4-4.

FIGS. 4-6 to 4-9 illustrate another embodiment of a rigidizing element50 with the tubes 42 attached thereto. As illustrated, the rigidizingelement 50 may be structured to extend under the interfacing structure,the manifold, and/or the back strap in use.

The rigidizing element 50 may have a varying thickness along its length,e.g., to vary the stiffness or rigidity of the tube 42 along its length.For example, the rigidizing element 50 may be thinner at the patient'scheeks and thicker at the top of the patient's head. In an embodiment,the rigidizing element 50 and/or tube 42 may be structured toaccommodate a respective arm of patient eyeglasses.

In an embodiment, the rigidizing element 50 may be cut and/or formedfrom thin plastic sheet, e.g., 0.5 mm high impact polystyrene (or EPPfoam). However, other suitable materials are possible, e.g., textile,nylon, polypropylene, high duro silicones, elastomers, etc., and therigidizing element may have other suitable wall thicknesses, e.g., inthe range of about 0.3 mm to 5 mm.

In an embodiment, each tubing/rigidizer sub-assembly may have a totalthickness (e.g., thickness of collapsed tubing/rigidizer) of about 1.5mm, e.g., 0.5 mm rigidizing element, 0.5 mm tube wall on one side, and0.5 mm tube wall on opposite side. However, the total thickness may bemore or less depending on application, e.g., 1-10 mm, 1-5 mm, less than5 mm, about 10 mm, about 5 mm, and/or about 3 mm. It should beappreciated that the wall thickness of the tube and/or rigidizer may beadjusted for comfort and/or robustness, e.g., wall thicknessesthickened. The wall thickness of the tube and rigidizer is preferably asthin as possible, but may be thickened so as to be more shape-holding,self-supporting, and/or robust.

In an embodiment, a separate rigidizing element 50 may be employed. Forexample, see International Patent Application PCT/AU03/00458 (publishedas WO 03/090827), which is incorporated herein by reference in itsentirety.

In an embodiment, a separate rigidizing element 50 may be formed, andthen attached to the respective tube 42, e.g., by an adhesive or by amechanical interlocking arrangement.

In another embodiment, the rigidizing element 50 may be co-molded orco-extruded with the respective tube 42. That is, the tube 42 andrigidizing element 50 may form an integral, one-piece structure.

In another embodiment, the rigidizing element may made of polypropyleneand the tube may be made of a thermoplastic elastomer of a gradesuitable for welding/co-molding to the polypropylene rigidizing element.

In an alternative embodiment, the rigidizing element may includemultiple components that are adjustable or movable with respect to oneanother, e.g., slidable, to adjust the position and/or rigidity providedby the rigidizing element.

1.4 Back Strap

In the illustrated embodiment, a back strap 60 is provided to thetubing/rigidizer sub-assembly (e.g., see FIGS. 1-2, 1-6, and 6-1 to6-4). The back strap 60 is adapted to be positioned generally on thepatient's occipital bone in use to facilitate stabilizing the patientinterface on the patient's head. The back strap 60 may also assist inproviding an interfacing force against the interfacing surface, e.g.,under the patient's nose.

In an embodiment, the back strap 60 (also referred to as anelasto-stabilizer or elastic stabilizer) includes a length of elasticstrap 62. The two ends of the elastic strap 62 are attached to thetubing/rigidizer sub-assembly, e.g., via eyes 46 provided to respectivetubes 42 as shown in FIGS. 6-3 and 6-4.

In use, the back strap 60 may sit in a range of positions on thepatient's head and still effect an adequate interfacing force in bothmagnitude and direction. This arrangement allows some variation in fitsize, and aids the patient's comfort in moving the back strap 60 to themost comfortable of locations, e.g., higher or lower positions at theback of the patient's head as shown in FIGS. 6-3 and 6-4. The elasticityof the back strap allows the patient interface to fit a broad range ofthe population, e.g., 80-90% of the population.

The back strap 60 is primarily used to maintain the patient interface onthe patient's head, rather than provide an interfacing force. That is,the interfacing structure 20 does not require high tension for interface(as described below), and therefore the back strap 60 does not need tobe relied on for tension for an interfacing force.

In an embodiment, the strap 62 may have selected elastic properties,e.g., from zero extension to a relatively small extension, the tensionrises and plateaus. The tension may remain generally similar over arelatively large further extension until it reaches the fully extendedelastic limit.

A range of alternative straps 62 may be provided with the patientinterface for use with different size heads, e.g., different elasticity,thickness, length, etc.

The back strap 60 may have other suitable configurations withselectively adjustable lengths, e.g., baseball cap adjuster (e.g., seeFIG. 10-4), hook and loop material, ladder lock, adjustable elastic. Inan embodiment, as shown in FIG. 6-5, the back strap may include siderigid portions 65 (e.g., integrally formed with the rigidizing element50) and an elastic strap 62 joining the free ends of the rigid portions65.

In yet another alternative embodiment, the back strap may be constructedof the same material as the tubes, e.g., tube and back strap co-moldedto a rigidizing element. In an embodiment, the two sides of the patientinterface may be molded at once, e.g., two rigidizing elements heldtogether by the back strap which blends into both rigidizing elements.To complete the patient interface, the tubes would be engaged with amanifold and an interfacing structure.

In an alternative embodiment, the back strap may be replaced by earanchors adapted to engage the patient's ears and support the patientinterface on the patient's face.

In another embodiment, the back strap may only extend across part of theocciput (e.g., the back strap comprises resilient fingers that extendinwards from each side and press against the occiput to provide arearwardly directed force).

1.5 Manifold

The manifold 70 is provided to interconnect the two tubes 42 and directair flowing from a suitable source, e.g., a blower, into the two tubes42 (e.g., see FIGS. 1-2, 1-4, and 1-6). As best shown in FIG. 2-2, themanifold 70 is generally T-shaped and includes a base portion 72 and aninlet tube portion 74 that is coupled (e.g., movably coupled via a balljoint, hinge, general flexibility, etc.) to the base portion 72. In anembodiment, the manifold 70 is designed to be sleek and to have a formcontinuous with the shape of the patient's head and the patientinterface, e.g., unobtrusive. For example, the manifold may have arelatively flat form or low profile to minimize the height or angle ofair delivery.

The manifold provides a transition from the air delivery tubing leadingfrom the PAP device to the inlet tubing leading to the interfacingstructure. Thus, the manifold transitions non-crushable tubing of theair delivery tubing to crushable tubing of the inlet tubing. Also, themanifold transitions tubing profile, e.g., relatively round tubing ofthe air delivery tubing to relatively flat tubing of the inlet tubing.

The base portion 72 includes opposing tube portions 25 adapted to engagerespective tubes 42, e.g., with a friction fit. The cross-sectionalshape of the tube portions 25 may be non-circular and correspond to thecross-sectional shape of the tubes 42. The base portion 72 may be curvedto match the shape of the patient's head and is otherwise suitablycontoured such that it can rest and sit substantially flush with the topof the patient's head in use. However, the base portion may includeother suitable connections or air holding bonds with the tubes.

The inlet tube portion 74 may be fixed to the base portion 72, or theinlet tube portion 74 may be movably coupled, e.g., swivel, to the baseportion 72 so that the inlet tube portion 74 may be angled with respectto the base portion 72 in use. The swivel arrangement may provide 360°rotation or any other suitable angle range. The inlet tube portion 74has an inlet tube 75, e.g., 15 mm diameter, adapted to connect to an airdelivery tube T1 (e.g., see FIGS. 1-2, 1-7, and 2-2) connected to asuitable air delivery source, e.g., a blower.

In an embodiment, the manifold 70 and tubes 42 may be integrally formedas a one-piece structure, e.g., to reduce the number of parts.

In an embodiment, the manifold may be structured to control dynamic flowand/or reduce noise.

1.5.1 Location

The manifold 70 is positioned in a region on the top of the patient'shead that does not interfere with a pillow when the patient interface isused (e.g., see FIGS. 1-2, 1-4, and 1-7). That is, the manifold 70directs the air delivery tube T1 out of the bed so it does not interferewith the pillow and does not pass along the patient's body. In anembodiment, the manifold 70 may be positioned on the crown of thepatient's head, e.g., generally in the plane of the patient's ears. Forexample, the manifold 70 may be positioned generally in the region ofthe Bregma in use.

An advantage of this approach is that tube drag does not directly affectthe interface in use. For example, by placing the manifold 70 near thecrown of the head, it is positioned furthest from the interfacingstructure 20, so if the air delivery tube is yanked or moved, themovement has less affect on the interface, e.g., by changing the loaddistribution in the interfacing region, and therefore increases thestability of the interface. Also, the positioning of the manifoldenables the tube connection to the mask to be less obtrusive by avoidingthe patient's field of vision.

The manifold may provide multiple functions or utilities. For example,the manifold may provide a point of reference or anchor point for thepatient interface. That is, the manifold may act as a head support orstabilizer, an air delivery conduit, and an inlet tubing attachmentpoint. In addition, the manifold resists tube drag as described above.

1.5.2 Swiveling Features

In an embodiment, the manifold 70 is generally T-shaped and defines twogenerally perpendicular axes, i.e., the base portion 72 along a firstaxis and the inlet tube portion 74 along a second axis that isperpendicular to the first axis.

The manifold 70 may incorporate swiveling features that allow themanifold 70 to swivel or hinge about one or both axes (e.g., see FIG.7-1). FIG. 7-2 illustrates a manifold 270 having a ball and socketarrangement that allows the inlet tube portion 274 to rotate or swivelwith respect to the base portion 272. The base portion and/or inlet tubeportion may incorporate one or more stops to limit swiveling in use. Theswiveling feature allows the air delivery tube to be suitably angledwith respect to the patient interface, e.g., so the air delivery tubedoes not extend into the wall or bed headboard.

1.5.3 Offset Attachment

In the illustrated embodiment, the manifold 70 is positioned at the topof the patient's head, e.g., see FIGS. 1-2, 1-4, and 1-7. In alternativeembodiments, the manifold 70 may be offset from the top of the patient'shead, e.g., positioned at a side of the patient's head. This offsetarrangement may provide more comfort as there may be less drag(particularly if the patient sleeps on the opposite side of their head).This arrangement may also facilitate an alternative tube attachment androuting, e.g., a snorkel-like side tube routing.

The length of the tubes 42 may be selected to adjust the manifold 70 toa position where the patient can view and more easily manipulate airdelivery tube connections.

In an embodiment, the manifold 70 may have an adjustable connection,e.g., sliding or translating coupling, so that two or more positions ofthe manifold (e.g., along a backstrap of the headgear) may be selected.

1.6 Location on Head

In the illustrated embodiment, the air delivery and stabilizing system30 includes two alternative, complementary air delivery pathways locatedon different parts of the patient's head (e.g., preferably either sideof the patient's face) so that a patient may roll through almost acomplete circle without occluding both pathways.

In an embodiment, the air delivery and stabilizing system 30 has agenerally oval or ring-shaped configuration (e.g., see FIGS. 8-1 to8-4). In use, each tube 42 of the system has one end that passesgenerally over the crown of the patient's head and the other end passesunder the patient's nose, as shown in FIG. 8-5. In this way, the airdelivery and stabilizing system 30 is outside the patient's eyes anddoes not interfere with the patient's vision or field of view and may besimply donned as one does a cap. In an alternative embodiment, thering-shaped configuration may incorporate a divider to split the ringshape, e.g., ring shape divided at manifold or under nose.

Each tube 42 of the air delivery and stabilizing system 30 passes alonga respective side of the patient's face between the patient's eye andear to provide an arrangement that does not obstruct the patient'svision. That is, each tube 42 is sufficiently spaced from the ear toreduce noise and sufficiently spaced from the eye so it does not affectthe field of view. In an embodiment, the tube 42 passes in a direct linefrom the patient's nose to the crown of the patient's head. However, thetube 42 is not limited to any specific path.

For example, as shown in FIG. 8-6, each tube 42 may pass within a regiondefined between a first boundary curve P1 and a second boundary curveP2. The first and second boundary curves P1, P1 are represented by twoidentical curves, one curve rotated with respect to the other curve. Thecurves are positioned so that they are both on the extremes of theregion. As illustrated, the first boundary curve P1 is adjacent to theeye at a position where it would impinge upon the patient's field ofview, and the second boundary curve P2 is adjacent the patient's ear.The second boundary curve P2 may be described as a position adjacent atop forward location on the patient's auricle where the auricle joinsthe patient's temple. Dimension B shows a head height. As illustrated,curve P2 stops on the crown of the patient's head. That is, if the curverepresented tubing, it would be substantially snug against the top ofthe patient's head. When the curve or tubing is rotated forward,dimension A shows the head height of a patient that this would fit. Asillustrated, a fit range delta AB is achievable using the samenon-adjustable tubing.

In an embodiment, the air delivery and stabilizing system 30 may passalong the upper jaw bone of the patient, e.g., avoid cheek and followfleshy areas of the patient's face. Also, in an embodiment, the airdelivery and stabilizing system 30 may reside over the mid-point of thepatient's temple in use. However, the air delivery and stabilizingsystem 30 may be sufficiently soft so that sensitive areas do not needto be avoided for comfort.

It should be appreciated that positioning of the air delivery andstabilizing system 30 on the patient's head does not critically dependon exact alignment with certain facial features as do prior art systems.That is, a satisfactory interface may be formed and retained by the airdelivery and stabilizing system 30 despite movement.

1.7 Other Aspects of System

1.7.1 Assembly

In a preferred embodiment, the patient interface 10 is structured suchthat little or no adjustment is needed to fit the patient interface tothe patient's head. Thus, the patient interface is relativelyself-locating, intuitive, auto-adjusting, easy fitting. In anembodiment, the patient interface may be assembled one handed, e.g.,slip on like a hat.

As noted above, the air delivery and stabilizing system 30 has agenerally oval or ring-shaped configuration, e.g., a generally truncatedelliptical cone or funnel. A tapering surface or conical-elliptical ringmay be provided between the inner and outer edges to define a contactsurface that engages the patient. Depending on the size of the patient'shead, the tapered contact surface will engage the patient's head indifferent positions. For example, if the patient has a larger head,patient interface may sit higher up on the patient's head. If thepatient has a smaller head, the patient interface may sit more towards arear portion of the patient's head. Once fit, the patient may adjust theback strap 60 as necessary. Thus, the patient may require a singleadjustment to fit the patient interface to his/her head. Further detailsof such an arrangement are disclosed in U.S. Provisional Application No.60/833,841, filed Jul. 28, 2006, which is incorporated herein byreference in its entirety.

In an embodiment, the oval or ring-shape configuration of the airdelivery and stabilizing system 30 may be adjustable, e.g., depending onpatient fit and/or preference. For example, as shown in FIG. 8-7 topand/or bottom portions of the “ring” may include an adjustment mechanism55 to allow adjustment of the ring size, e.g., depending on patient'shead size.

1.7.1.1 Method to Fit Patient

FIGS. 9-1 to 9-3 illustrate an exemplary method for fitting the patientinterface to a patient. As shown in FIG. 9-1, the interfacing structure20 may first be located under the patient's nose. Then, as shown in FIG.9-2, the air delivery and stabilizing system 30 may be rotated about theinterfacing structure 20 onto the patient's head. The patient interfaceis rotated, e.g., for X°, until the air delivery and stabilizing system30 engages the patient's head and prevents further movement. Finally, asshown in FIG. 9-3, the back strap 60 may be adjusted as necessary tocomfortably secure the patient interface on the patient's head.

In an alternative embodiment, the patient interface may be structured toprovide “staged fitting” of the patient interface. In such embodiment,one part of the patient interface (e.g., air delivery and stabilizingsystem) may be engaged with the patient and another part of the patientinterface (e.g., interfacing structure) may be subsequently engaged whenthe patient is ready for therapy to begin. This arrangement allows theair delivery and stabilizing system to be engaged with the patient'shead, while the interfacing structure is out of engagement. For example,in the case of an Adam's circuit (e.g., such as that shown in FIGS. 30-1to 30-4), the interfacing structure may be adapted to pivot upwards orlaterally into a “standby” position that is out of the patient's fieldof view and/or not engaged with the patient's face or nose. Theinterfacing structure may be moved from the “standby” position to afully operable/engaged position at the last minute just before thepatient is ready for therapy (e.g., before sleep). In one example, thetube or the joint between the tube and the mask may bepivotable/bendable/movable to move the mask away from the face whilestill maintaining the headgear in place. For example, FIG. 30-3illustrates an exemplary pivot 1915 at the joint between the tube andthe mask that allows the mask to move away from the face (e.g., to aposition shown in dashed lines).

1.7.1.2 Sizing

In the illustrated embodiment, the patient interface includes a singleadjustment point. The adjustment mechanism may be either passive (e.g.,elastic back strap) or require active adjustment (e.g., baseball capfitting) to provide a one-size fits all arrangement. In an embodiment,the adjustment point may be tailored or modified to fit the patient atthe point of sale, and then altered to prevent further adjustment, e.g.,tear off.

In an alternative embodiment, the patient interface may have anon-adjustable slip-on shape, e.g., like a shoe, with little or noelasticity. In this arrangement, the patient interface may be providedin many different sizes, e.g., up to 20 different sizes, 5, 10, 15, orany other number of sizes (e.g., small, medium, and large). Thisarrangement may be aided by high mechanical compliance of the sealinginterface to provide ample fit-range.

In another alternative embodiment, the patient interface may include amethod for adjusting the size (e.g., length) of the headgear in eitheror both of the upper and rear sections of the headgear.

1.7.1.3 Surface Properties

In embodiments, the air delivery and stabilizing system may be textured,colored, foamed, and/or flocked (e.g., lots of little bits of yarn orfluff adhered to it) to give a fabric-like feel or softness foraesthetics and/or comfort. For example, the tubing, rigidizing elements,back strap, and/or manifold may be textured, colored, foamed, and/orflocked.

In an alternative embodiment, a sock S may be provided to substantiallyenclose one or more portions of the tubing, rigidizing elements, backstrap, and/or manifold (e.g., see FIGS. 10-1 to 10-6). Such anarrangement is disclosed in U.S. Provisional Application No. 60/833,841,filed Jul. 28, 2006, which is incorporated herein by reference in itsentirety.

In another embodiment, different materials may be co-molded in the samemold to provide a one-piece, integrated structure. For example, insteadof providing a cover or sock to tubing, a fabric or cloth material maybe co-molded with silicone tubing to provide a one-piece, integratedtube with a fabric/cloth exterior surface and a silicone interiorsurface. In such embodiment, the fabric/cloth material may be placed ina mold and then silicone may be injected into the same mold so that itbonds with the fabric/cloth material and forms a one-piece, integratedtube.

In another embodiment, multiple portions of the patient interface may beco-molded in the same mold with different materials to provide aone-piece, integrated structure. For example, a fabric/cloth materialmay be co-molded with tubing constructed of a first material, a manifoldconstructed of a second material, and a frame constructed of a thirdmaterial to provide a one-piece, integrated structure. In an embodiment,the first, second, and third materials may include the same materialwith different durometers or hardnesses, e.g., tubing constructed ofrelatively soft silicone and manifold and frame constructed ofrelatively hard silicone. Alternatively, the first, second, and thirdmaterials may include different polymers or materials. Further, eachportion of the patient interface may include regions with differentproperties, e.g., end portions of the tubing may be harder than anintermediate portion of the tubing. In such embodiment, the fabric/clothmaterial may be placed in a mold and then the first, second, and thirdmaterials may be injected into the same mold so that all the materialsbond and form a one-piece, integrated structure, e.g., integrally formedtubing, manifold, frame with fabric/cloth cover.

In another embodiment, the tubing, rigidizing elements, manifold, and/orback strap may include silicone or other elastic beading for grip. Thisarrangement may be particularly useful for patient's with bald heads asthe beading is adapted to grip the bald head and prevent sliding ormovement of the patient interface with respect to the patient's head inuse. In an embodiment, the patient interface may be reversible so thatthe beading may be selectively used, e.g., depending on whether thepatient is bald. For example, fabric may be provided on one side andbeading may be provided on the opposite side so that the patient may useone or the other depending on preference, e.g., beading oriented towardsthe patient's head for bald heads and fabric oriented towards thepatient's head for hairy heads.

1.7.1.4 Manufacture

In an embodiment, each tube 42 may be manufactured as a bifurcated tubehaving a co-molded thickened section that forms a rigidizer.

In another embodiment, each tube 42 may be constructed of two pieces,i.e., a top half and a bottom half attached to the top half. In anexemplary embodiment, the top half may be constructed of textile or foam(e.g., with a sealing layer), and the bottom half may constitute arigidizer with a skin-contacting portion.

1.7.2 Low Visual Obstruction

The patient interface may incorporate one or more regions havingdifferent colors (color contrast), patterns, and/or surface textures toreduce visual impact or distraction to the user. Such coloring,patterning, and/or surface texturing may be incorporated into thetubing, rigidizing elements, manifold, back strap, and/or interfacingstructure. Alternatively, a sock having coloring, patterning, and/orsurface texturing may be provided to the patient interface.

For example, FIGS. 10-1 to 10-10-6 illustrate a patient interfaceincluding a cover or sock S having a two-tone color scheme, e.g., a darkcolor D and a light color L. Such a patient interface is described inU.S. Provisional Application No. 60/833,841, filed Jul. 28, 2006, whichis incorporated herein by reference in its entirety. As illustrated, thedark color D is positioned adjacent the field of vision. Thisarrangement provides a low impact, unobtrusive, sleek look that is lessvisually obtrusive to the patient and others.

Specifically, bright colors are more easily picked up by the patient andshould be avoided in the field of view as they are more likely to causea distraction than darker colors, e.g., bright colors reflect light intopatient's eyes. Thus, the dark color D is positioned adjacent the fieldof vision to minimize visual obstruction or obtrusiveness. In anembodiment, the patient interface may only be visible to the patient atthe very outer limits of their field of view, e.g., only the section ofthe patient interface which rests lower than the patient's eye level maybe visible. Further, the dark color D may seem to disappear at theextremities of the field of view resulting in the patient undergoingvery little visual obstruction.

Also, the two-tone textile cover S may slim the perception of the sizeof the patient interface on the patient's face. That is, thisarrangement has the functional advantage that lighter colors, e.g.,white, can be incorporated into the cover that make the relevant regionlook smaller, slimmer, or less bulky. Thus, the patient interface has alower visual impact (e.g., less aesthetically obtrusive). In addition,the patient interface may be more fashionable like clothing. Inalternative embodiments, one or more light colored lines, e.g., whitelines, may be incorporated into the cover. Also, in an embodiment, theinterface of the interfacing structure may include a darker color toreduce its visual obstruction.

It should be appreciated that different colors, patterns, and/or surfacetexture may be selected for different users. In an embodiment, the covermay be transparent or selected to blend in with the patient's skin,e.g., camouflaged or skin color. For example, if the patient hasrelatively darker skin, the cover could be black or dark brown to blendwith the patient's skin. In an alternative embodiment, the color and/ortexture of the cover may be selected to match the patient's hair.

1.7.3 Valve

In an embodiment, as shown in FIG. 11-1, a valve V, e.g., mechanicalgate, may be provided to the patient interface that is adapted to openwhen both tubes 42 are occluded. For example, the valve V may remainclosed if the interior pressure P_(int) is over 2 cmH₂O, and the valvemay open if the interior pressure P_(int) is less than 2 cmH₂O therebyallowing the patient to breathe if both tubes 42 are occluded.

1.7.4 Connection to a Blower

In an embodiment, the patient interface 10 may be connected to theblower by a pair of air delivery tubes, i.e., a 15 mm tube and a 22 mmtube. As shown in FIG. 1-2, a 15 mm tube T1 connects the manifold 70 toa 22 mm tube T2, and the 22 mm tube T2 connects the 15 mm tube T1 to theblower. A quick-release connector 90 is provided at the transitionbetween the 15 mm and 22 mm tubes T1, T2 to allow quick release of the15 mm and 22 mm tubes T1, T2, and hence quick release of the patientinterface 10 from the blower. In an alternative embodiment, aquick-release connector may be provided to the manifold 70 positionedadjacent the top of the patient's head. The quick-release connector mayhave any suitable structure to facilitate tubing assembly/disassembly,e.g., mechanical interlock, friction fit, screw-type arrangement, etc.The various connection points facilitates assembly/disassembly of thepatient interface system which facilitates cleaning, adjustment, etc.

The 15 mm tube T1 has a suitable length to allow easy patient access tothe quick-release connector 90, e.g., quick-release connector 90 inpatient's field of view. Also, the 15 mm tube T1 has a suitable lengthso that the quick-release connector 90 may be positioned sufficientlyaway from the patient interface so the weight of the quick-releaseconnector may be supported by the bed mattress or other support system.

Impedance in the system is as little as possible so that therapy doesnot vary significantly whether one or both tubes 42 are open. Therefore,the system is designed such that the hydraulic restriction or bottleneckis provided upstream of the patient interface including the case inwhich only one of the tubes 42 is open, i.e., the hydraulic bottleneckis provided in the manifold 70 or anywhere upstream of the manifold 70(e.g., in the 15 mm tube and/or in the 22 mm tube).

Impedance is at least partially based on tube length. In the illustratedembodiment, the tubing is designed such that the tubes 42 are shorterthan each of the 15 mm tube and the 22 mm tube, e.g., 15 mm and 22 mmtubes at least 40-50 cm long. In an embodiment, the 22 mm inlet tube maybe about 2 m long and the 15 mm inlet tube may be about 70-75 cm long,with the bottleneck in the 22 mm inlet tube due to its length. However,other suitable lengths are possible.

In an embodiment, the air delivery tubing that leads to the manifold mayhave a look and feel similar to the inlet tubes 42. The air deliverytubing may have a smooth, noiseless outer portion, e.g., outer portionconstructed of a material that is soft to the touch and provides soundinsulation. The air delivery tubing may provide continuity of form fromthe PAP device or blower to the manifold of the patient interface.

1.7.5.1 Clip to Isolate Tube Drag

A clip or clamp may be provided to either air delivery tube T1, T2and/or quick release connector 90 that is adapted to attach to a bedheadboard or other support system. The clip or clamp supports the airdelivery tube and/or quick release connector on the bed headboard orother support system to isolate tube drag from the patient interface. Inan embodiment, the clip or clamp may be magnetic to allow magneticattachment.

For example, FIG. 12-1 illustrates the quick release connector 90magnetically attached to a headboard, FIG. 12-2 illustrates a clip 92adapted to attach the tube T1 to a headboard, and FIG. 12-3 illustratesthe tube T1 clipped to the patient interface.

1.7.5.2 Switch to Turn CPAP Therapy On/Off

A switch may be provided along any suitable portion of the patientinterface that is adapted to turn the blower providing CPAP therapy onand/or off. For example, the switch may be provided on the air deliverytube or quick release connector. In an embodiment, the switch may bewirelessly communicated with the blower.

1.7.6 Inflatable Headgear

In an alternative embodiment, inflatable tubes may be provided around arelatively more rigid air delivery tube to insulate the air deliverytube from the patient's face.

1.7.7 Moveable Tubes

In an alternative embodiment, tubes may be provided that are adapted tomove out of the way when the patient's head is turned.

2. Interfacing Structure

2.1 Background and Summary

Known patient interfaces typically include a silicone seal that isadapted to seal around and/or within the patient's nose and/or mouth.Sealing mechanisms may be categorized as: (1) a flap-type seal, (2) abulk compression or gasket-type seal, or (3) a combination of (1) & (2).A flap-type seal may utilize the mechanics of a flexible membrane toachieve a reliably sealing interface. Compared to a flap-type seal thatworks by deflection of the flap, a bulk material seal works bycompression of the material. A preferred interfacing structure of thepresent invention utilizes foam in the form of a bulk compression typeseal although the foam may take other forms.

One aspect of the present invention relates to an interfacing structure20 in the form of an under-the-nose interface 80 made of foam (e.g., seeFIGS. 1-6, 1-8, 1-10, 13-1, 13-2) that provides an effective andsuperiorly comfortable engagement with the underside of the patient'snose in use. In embodiments, the under-the-nose interface may be in theform of a cupping portion, prongs, or pillows. The foam interface 80 maybe supported by a support and/or frame or shell adapted to communicatewith respective tubes 42 of the air delivery and stabilizing system 30described above.

For example, as shown in FIGS. 1-6, 1-8, and 1-10, the foam interface 80may be provided to a relatively stiff shell or frame 22, e.g., formed ofsilicone, including tube portions 25 adapted to engage respective endsof the tubes 42, e.g., via friction fit.

In another embodiment, as shown in FIGS. 13-1 to 13-2, the foaminterface 80 may be provided to a cylindrical support or base 82, e.g.,constructed of silicone, and the cylindrical support 82 is adapted to beattached to a relatively rigid frame (not shown) adapted to engagerespective ends of the tubes 42. The cylindrical support 82 may have asubstantially similar structure to the base portion of a nozzle assembly(with the nozzles removed) as disclosed in U.S. patent application Ser.No. 10/781,929, the entirety of which is incorporated herein byreference. The flexibility of the cylindrical support 82 adds complianceto the interface. The cylindrical support 82 may have a split base to beconnected with a channel in the frame. In an embodiment, the interface,cylindrical support, and/or frame may be adapted to rotate to addfurther compliance and/or adjustment to the interface. In an embodiment,the rotational adjustment and positioning may be maintained through theuse of friction, indexing, and locking mechanisms.

In the illustrated embodiment, the foam interface 80 is constructed of avery soft foam that is compliant enough to gently cradle the patient'snose and provide an unobtrusive and comfortable nasal interface, e.g.,under-the-nose foam interface. The under-the-nose foam interfaceprovides the visual freedom and unobtrusiveness of nasal prongs, withoutthe intrusiveness and potential discomfort of silicone prongs inside thepatient' nose.

One issue that has emerged with the prevalence of nasal prong interfacesis a recognizable decrease in breathing comfort where a cold, frictionalor burning sensation may be felt inside the nose from air rushingthrough the nose, particularly upon inhalation and higher pressures whenthe air travels at higher speeds through the nose. This sensation hasbeen dubbed the ‘jetting effect’. This jetting effect is thought to bepartially due to the air entering the nose in a channeled manner throughthe narrow prong orifices and impinging on sensitive nasal mucosa. Itmay also be attributed to air temperature and humidity. Thus, anotheradvantage of the under-the-nose foam interface is the elimination orminimization of the jetting effect that nasal prongs are known toproduce. This is because the air is not being forced through narroworifices inside the nostrils, but through a larger orifice that coversboth nostril openings. The exit of the foam interface remaining entirelyor predominantly outside of the nose allows for the impedance of theorifice to be matched to, or lower than, the nostril openings so thatflow is not restricted and formed into a jet stream inside the nose. Thefoam also has a diffusing effect at the boundary of the flow as itenters the nose. The irregular surface of the foam may add turbulence tothe boundary layer of the flow entering the nostrils and as suchnavigates the nostril cavity with less concentrated force on thesensitive anatomy inside the nose. This diffusing effect also allows forthe alignment of the interface with the nostril to be less critical withrespect to the generation of the jetting effect. The foam being slightlyair permeable also has the advantage of minimizing the aspects of thejetting effect that are attributable to humidity and temperature. Coldair and temperature variable air entering and exiting the nose can causean irritating sensation inside the nose with known interfaces. Uponexhalation, the foam may be infused with warm exhaled air, and uponsubsequent inhalation this small amount of warm air may reenter and/orheat the air stream that enters the nose therefore reducing the jettingeffect. Yet another advantage of the foam in relation to the jettingeffect is its ability to retain moisture (e.g., moist air), again due tothe permeable nature of the foam. Upon inhalation, the stored moisturemay add to the humidity of the inhaled air and reduce the jettingeffect.

In another embodiment, the under-the-nose interface may have a centralportion that divides the singular orifice into two. In this embodiment,the two resulting orifices may be size-matched, smaller than, or largerthan the nostrils.

In both of the aforementioned embodiments (single and double orifice),alignment of the orifices with the nostrils can be relaxed compared tonasal prong designs. This is a result of not having positively intrudingfeatures inside the nostrils. The interface allows for greater movementalong the surface of the skin without compromising the interface and/orseal. As a result of the very low hardness of the foam (e.g.,particularly the very soft viscoelastic grades), the foam may intrudeslightly inside the nostrils as it takes the shape of the anatomy it isinterfacing with.

In a preferred embodiment, the interface may be made from a very soft,viscoelastic polyurethane foam grade. One method of quantifying theviscoelastic nature of foam is to measure the rate of deformation orrecovery of the foam after it has been compressed. In an embodiment, therate of recovery is designed so that the interface remains comfortablyand sealingly engaged with the user's face while wearing the mask. Theviscoelastic nature has particular benefits for maintaining comfort andseal during movement while wearing the mask. In other embodiments, therange of viscoelasticity may range from a foam that has a very slow rateof recovery to a very fast rate of recovery.

Another aspect of an interfacing structure in accordance with apreferred embodiment of the present invention is its relatively slowrate of return compared to known interfacing structures. A silicone orother rigid elastomer cushion has a relatively fast rate of return inthe order of 5 to 10 cm/sec or higher. In one embodiment of theinvention, the interfacing structure has a rate of return of less thanabout 5 cm/sec. In a preferred embodiment, the rate of return is about 1cm/sec.

Rate of return can be measured by sandwiching a sample of bulk materialbetween a bottom flat, rigid plate and a top flat, rigid, light plate.The top plate is moved downwards by a predetermined distance,compressing the bulk material and then is released. The time it takesthe bulk material to raise the top plate to the original position ismeasured. The measure will be relative only, because the time taken toreturn to the original position will be dependant on the weight of theplate. The rate of return is equal to the thickness of the foam dividedby the time to return. A relatively fast rate of return will take placein under a second.

The preferred type of foam was measured using the above mentioned rateof return test and a very light top plate (of rigid foam) was used suchthat the weight of the top plate was negligible. The block of foamsandwiched between the two plates was 5 cm thick and was manuallysandwiched down until it was about 1 cm thick. It took 3.5 sec toreturn. This corresponds to a rate of return of about 1 cm/sec. Bycomparison, a typical prior art silicone membrane would return in underhalf a second.

A related material property is hysteresis. With reference to FIG. 14-1,another aspect of a preferred embodiment of the invention is a materialexhibiting hysteresis in the range of 25 to 35 percent.

It should be appreciated that the under-the-nose interface may beconstructed of other materials that form a cellular polymeric structure,e.g., polyethylene, polypropylene, silicone, latex rubber.

It should also be appreciated that the under-the-nose interface may beconstructed of other suitable material types and configurations, e.g.,textile covered foam, textile, textile strata, silicone (e.g., dual wallsilicone under-the-nose interface with membrane and undercushion),silicone foam.

In yet another embodiment, the foam interface features the foam actingas a HCH (Hygroscopic Condenser Humidifier) or HME (Heat and MoistureExchanger). This allows heat and moisture to be captured and returned tothe user's airway to increase breathing comfort as described above inrelation to the jetting effect.

The porous moisture absorbing and moisture retaining properties of thefoam allow for the addition of scented vaporous liquids to the interfacebefore or during the wearing of the interface. Such scents may or maynot be therapeutic in nature. The mechanical properties of the foam maybe modified (e.g., pore size, surface tension) to adjust the rate ofevaporation of the scented liquid. Similarly, the drying performance ofthe foam may be adjusted.

2.2 Bulk Material Properties

In the illustrated embodiment, the foam interface 80 is a very soft,flexible, visco-elastic foam (e.g., converted slabstock) that has asoft, comfortable feel against the patient's skin and a hardness orstiffness that resembles the soft fleshy anatomy of the patient's facewith properties as defined in FIG. 14-1. If sufficient stability andsealing reaction force is afforded by the patient interface design, thehardness will ideally be softer than the fleshy anatomy of the face. Thehardness of the interface being softer than the anatomy it isinterfacing with maximizes comfort by allowing for minimal pressure tobe applied to the face to achieve an interface or pressure increase tothe user's airway (i.e., low hardness and high visco-elasticity allowslow contact pressure and maximal conformance to the contours of thepatient's face (shape forming ability)). The interfacing dynamics arealso improved whereby the interface conforms around the facial anatomymore so than the interface deforming the face, e.g., interface canaccommodate relatively small features on the patient's face (e.g.,facial creases and features which are the size of dimples on a golfball, undulations, etc.).

The foam interface provides a static seal that may allow lower straptension from headgear to create a sealing force and a dynamic seal thatallows the interface to withstand macro-movement from a patient rollingaround in bed and maintain an interface. Such interface properties aredescribed in greater detail below.

The visco-elastic foam has a much more natural feeling against thepatient's skin compared to conventional silicone interfaces, which mayhave a sweaty, plastic feel. The foam may include a moisture content,e.g., slightly moist or damp after usage or washing, which may provide acooling effect or a refreshing feel when air flows through the foam inuse.

In a preferred embodiment, the foam interface 80 may be a low hardness,low to high density, soft, low odor, low air-permeability, lowresiliency, low isocyanate index polyether polyurethane foam with a veryfine heterogeneous cell structure and visco-elastic behavior. The foamalso features color and colorfastness to a pantone reference. Inaddition, the foam may provide moisture wicking ability to wick moistureor sweat from the patient's skin. In an embodiment, properties of thefoam interface may vary along its thickness, e.g., density, porosity, orhardness of the foam may vary in different layers, and/or properties ofthe foam interface may vary along its perimeter, e.g., breathability mayvary in different regions of the interface's perimeter. Visco-elasticityis the range of recovery of the foam interface from compression.

For example, FIGS. 13-3 to 13-4 illustrate foam with a mixedheterogeneous cell structure and FIGS. 13-7 a and 13-7 b illustrate foamwith a layered heterogeneous cell structure. FIGS. 13-7 a and 13-7 balso illustrate how properties of foam may vary in different layers. Asshown in FIGS. 13-7 a and 13-7 b, the foam may include three layers,i.e., small, medium, and large cell layers. In FIG. 13-7 a, small celllayers are near the surface and the cell layers get gradually largertowards the interior, and in FIG. 13-7 b, large cell layers are near thesurface and the cell layers get gradually smaller towards the interior.However, the layers may have any suitable arrangement, e.g., mediumlayer near surface, then small and large layers towards interior. Suchcell structure arrangements may be achieved depending on the choice ofmanufacturing methods.

FIG. 13-7 c illustrates a foam including a reinforcement element R,e.g., constructed of a laminate of stiffer foam, plastic, or metal, atan interior portion thereof. The reinforcement element R is structuredto add rigidity to the foam in use. The foam portions on each side ofthe reinforcement element may include a homogeneous structure (as shownin FIG. 13-7 c) and/or a heterogeneous structure (layered or mixed). Ina preferred embodiment, the reinforcement element R may be situated onone side of the foam interface, e.g., the bottom/non-facial contactingsurface. In this way, the reinforcement may provide dual functionality,i.e., providing both reinforcement and a method for attachment to themask (e.g., mechanical interference fit, Velcro, pressure-sensitiveadhesive).

FIG. 14-1 illustrates a table of mechanical properties of a foaminterface according to an embodiment of the present invention.

One aspect of a preferred embodiment of the present invention is the lowhardness of the foam (or other soft material) of the sealing structure.Hardness can be defined in terms of both indentation and compressionhardness. A preferred indentation hardness is in the range of 25 to 80 Nat 40% while a preferred compression hardness is in the range of 0.4 to1.5 kPa.

The foam interface according to an embodiment of the present inventionmay also include a degree of one or more of the followingcharacteristics:

Cellular foam type—flexible polyurethane;

Polyurethane type—polyether based;

Cell structure—control of the cell structure of the foam is desirable tocontrol the feel (also known as the “hand”) and look of the foam. Thecell structure may be controlled to have a more heterogeneous or morehomogeneous distribution of cell sizes, and this can affect the feel andlook of the foam in various ways. The foam can also be produced to havea cell structure with varying degrees of open and closed cell content,which can affect several aspects of the foam's properties, e.g., air andmoisture permeability.

Sealing—foam with a high closed cell content may have sufficiently lowpermeability so that a positive pressure seal may be created inside theinterface upon compression against the skin. In an embodiment, the foammay include significantly more closed cells than open cells, e.g., 90%closed and 10% open. The compressive force provided by the foam to sealis therefore a function of the mechanical stiffness of the foam, andalso the compressive stiffness added by having pressurized air insidethe foam's cellular structure (e.g., air spring/air pressure stiffness).In this manner, the sealing function is provided while still allowing asmall deliberate flow of air to escape along the surface and through thebody of the foam structure. In embodiments, the foam has a cut, opencellular structure against the skin, however other embodiments mayinclude foam that has a permeable skin. Another embodiment may have foamthat is skinned (both permeable and impermeable skin) only on the skincontacting surfaces of the interface, leaving flow to pass through thebody of the foam structure rather than along the skin-contactingsurface.

Air permeability—the foam can be produced to have a controlled range ofair permeability. Typically, for a sealing application, foam would beproduced to have the highest closed cell content possible to prevent airor moisture from passing through the foam. In an embodiment, it may bedesirable that there is allowed a relatively small amount of airpermeability. This has several distinct advantages in relation to boththe comfort and sealing performance of the interface when it is worn,e.g., allowing a small, diffuse flow to pass through the foam gives theskin in contact with the interface the ability to breathe, and forexcess moisture to be removed from the interface during use;

Air permeability durability—maintenance of the desired level of airpermeability throughout the component usage life is desirable becausethe flow through all elements of the mask system may be required to meeta given specification. Changes in air permeability can occur with cyclicmechanical compression loading therefore measures that are taken toimprove the durability of the foam structure in relation to itspermeability are an advantage. In a preferred embodiment, a polyurethaneformulation that uses an MDI (Methylene-Bis-Di-Isocyanate) typeisocyanate may be chosen to give the foam a durable closed cell content;

Odor/Volatiles—As the foam is intended to be used in close proximity toa person's nose, any measure that can be taken to minimize orpreferentially modify the odor is an advantage. In a preferredembodiment, a polyurethane formulation that uses an MDI(Methylene-Bis-Di-Isocyanate) type isocyanate is a preferred choice tominimize odor;

Particulates—The chemistry and processing of the foam is chosen suchthat the foam component will not produce small particles that may beinhaled during use;

Feel/Hand—There are aesthetic advantages to producing the foam to have afeel that is silky and soft. In a preferred embodiment, the foam isproduced to have a fine cell heterogeneous cell structure to maximizethe smooth feel of the foam, and this can also aid in minimizing thepotential for skin abrasion and irritation. Another aspect of the foam'smechanical properties that may aid its aesthetic appeal is for it to beproduced with a high level of visco-elasticity, which gives the foam anintriguing interactive property;

Durability—The foam chemistry may be chosen so that it maintains itsdesired mechanical properties for the required shelf life and usage lifeof the component (e.g., foam structure may be manipulated to havepredetermined life span, ranging from single use to long term use). Thisaffords the advantage of providing a renewable product to the user onsuitable replacement frequencies whereby the foam component may bereplaced on a daily, weekly, monthly or other basis. Components that arepackaged in predetermined multiples may then be supplied to the user,e.g., on a 3, 6, or 12 monthly or other suitable basis;

Thermal stability—the foam may be designed to withstand the thermalconditions of storage and transportation. It may also be designed towithstand the temperatures of disinfection and sterilization processes(e.g., autoclaving temperatures and potentially temperatures up to 180degrees);

UV stability/Light fastness—the foam material will not breakdown easilywith light exposure;

Swelling resistance—the foam component may be designed to have givenswelling characteristics when saturated with water or other liquids. Itmay be designed to minimize or maximize its change in geometry dependingon the desired characteristics of the foam under saturated conditions(e.g., swelling may be desirable to open the pores of the foam forcleaning, swelling may be undesirable to preserve the functionalgeometry under saturated conditions);

Dryability—the foam component may be designed to become dry underspecific time constraints and environmental conditions, e.g., thecomponent may be moist after usage or cleaning procedures so it may bedesirable for the component to dry as quickly as possible prior tofurther usage, e.g., moisture in the interface may be desirable undercertain usage conditions (cool feeling against the skin in hotconditions), so it may be advantageous for the component to retainmoisture for longer periods of time, e.g., the component may be designedto dry during use by the air flowing through the material under thepressurized conditions during CPAP therapy (self drying);

Hydrolytic stability—the chemical formulation of the polyurethane foammay be chosen to give the foam a desired level of hydrolytic stability.The choice of a polyether type polyol over a polyester type polyol maygive the foam improved resistance to hydrolysis (mechanical breakdown inthe presence of moisture);

Color—the foam component may be colored to a defined Pantone reference(e.g. PC287);

Color fastness—A key challenge with respect to the use of foams isdiscoloration, both from natural aging and environmental factors duringuse. This is particularly an issue with natural and light colored foams.One method of countering discoloration is to deliberately color the foamwith colors that change less obviously with age and usage (e.g., darkerand more intense colors may discolor less). That is to say that thecoloring of the foam has a functional attribute in preserving theperceived utility and cleanliness of the component during its usagelife. Another issue that may occur is the running of any dye or pigmentthat is removably included in the foam structure. In a preferredembodiment, a reactive colorant is incorporated so that color reactsinto the foam chemical structure so that it becomes part of thepolyurethane chemical background, e.g., Reactint™ Colorants fromMilliken Chemical. This gives the foam a significant advantage in itsintended application to resist discoloration such that the productpresents well upon initial usage and remains presentable with ongoinguse;

Slabstock packaging—slabstock foam may be wrapped and sealed in plasticfor shipment and storage;

Component packaging and distribution methods—The foam interfacecomponents may be designed to have a predetermined usage life. In thiscase, the component may need to be replaced on a more frequent basisthan that which is currently known in the industry. For convenience ofreplacement, the component may be packaged to include multiplecomponents in one package (e.g., box or carton). For example, one box orcarton of components may include 50 components, 100 components, monthlysupply of components, yearly supply of components, or other suitablebasis. Components may be individually packaged and manufactured as partof a continuous perforated strip and provided in one package (e.g.,single foam interface in one package similar to a condom wrapper havingtwo side walls sealed about their perimeter). The components may be ingrouped or solitary component cells. In an embodiment, a significantadvantage is afforded by vacuum packaging the components. This form ofpackaging offers protection against aging from environmental factors(e.g., oxygen, humidity), as well as the ability to provide thecomponent in a customized micro-environment (e.g., inert gases toprevent aging, scented gases for therapeutic and non-therapeuticpurposes, color, flavor). Vacuum packaging also offers a significantadvantage in reducing the physical volume of the product for shippingefficiency and logistical convenience. The foam can be compressed forextended periods of time—weeks or months—and still return to itsuncompressed shape when the package is opened. FIG. 14-3 is a schematicview of a rotatable dispenser or reel D adapted to dispense individualpackages P containing a foam interface, e.g., continuous stream ofindividual packages separated by perforations to allow perforatedtear-off. However, the components may be separated by other suitablefrangible or breakable connections.

Machinability—foam may be produced to be sufficiently dense and hard sothat it can be machined into intricate 3D geometries;

Biocompatibility—Biological safety (biocompatibility) is paramount inthe main intended applications for the foam. It must therefore not emitany harmful volatiles or have any harmful or irritating interactionswith the human body. The chemistry and processing of foam is chosen toproduce a foam that is in compliance with ISO 10993 biocompatibilitystandards;

Microbial growth—The foam structure may provide an environment thathouses potential microbial (e.g., bacterial, fungal) growth,particularly in the presence of warmth and humidity and in closeproximity to the nose. Any measures that can be inhibitory to the growthof fungus and bacteria may be desirable to preserve the cleanlinessand/or prolong the usage life of the component. Typically, this isachieved by using non-porous materials or skinned porous materials thatare minimally absorbent and easily cleanable for components that are inintimate contact with the user. However, due to the significantadvantages for comfort and sealing performance in using a revealed, cutor open cellular structure (e.g., cut foam) against the face (asoutlined in this disclosure), other methods must be pursued to addresscleanliness and longevity of the component. In embodiments, the foaminterface component is configured to be replaced at suitable frequencies(e.g., daily, weekly, monthly or other suitable regime). Suitablecleaning and maintenance regimes may also be recommended for thecomponent (e.g., washing, drying, cleaning solutions (e.g., isopropylalcohol), steaming, microwave sterilization). Another method to inhibitmicrobial growth is to include an antibacterial or antimicrobial agent(e.g., AEGIS brand antimicrobial for polyurethane foams) into the foamchemistry; and

Recyclable/Biodegradable—As the foam interface may be a frequentlyreplaced component, the foam grade may be selected to be degradablewithin a chosen timeframe for minimal environmental impact. This may beexpressed as a half life for the material to break down in landfill. Inan embodiment, the foam is designed to break down in a time frame thatis much less than materials known in the industry (e.g., silicone,skinned porous structures, gels). This may be achieved by augmenting thechemistry of the foam and porous structure of the foam to allow theingress of landfill and microorganisms that aid the breakdown of thefoam. Another significant advantage of the foam that minimizesenvironmental impact is that the material is much softer and of muchlower densities than typical materials known in the industry, meaningthat the material may be easily compressed and take up far less space inlandfill.

As noted above, the foam interface components may be availableindividually and/or in box sets or cartons. This arrangement providesthe possibility of a broad range of distribution channels, e.g.,available via home-healthcare dealer, chemist, internet, etc.

In an embodiment, when the interface component wears out or needsreplacement, the patient may order a box when needed or a replacementbox (e.g., including daily-use interface components) may be periodicallysent out to a patient, e.g., patient signs up for 1 year supply withmonthly delivery.

This arrangement provides repeat business for a home-healthcare dealer.Also, this arrangement creates assembly line efficiencies because anassembly step (i.e., attachment of interface component to frame) istransferred to the patient. This arrangement may be adapted to reduceshipping by setting up manufacturing locally. In addition, thisarrangement may provide an advantage to sleep labs because they do notneed to sterilize, but just use disposable interface components.

In an embodiment, the packaging of the component may reflect replacementor reordering requirements. For example, the last items in a box may bepackaged differently to indicate “end of supply”. In another example,the packaging may include different colors to indicate different days,weeks, months, etc.

As noted above, the foam structure may have a certain usage life or lifespan. According to an embodiment of the present invention, the foamstructure may include an end-of-life indicator to indicate that thisusage life has been reached.

For example, the end-of-life indicator may include one or more of thefollowing: pH based color change (microbes produce acid to cause colorchange at replacement frequency); dirt/color changes; environmentalaging (take environmental gases out of packaging); adhesive deteriorateswith time (provides single assembly so patient cannot remove componentwithout destroying it—cohesive strength of glue greater than adhesive);and/or packaging include color guides that you match the component tosee whether it needs replacement.

2.3 Surface Properties

The foam interface 80 may be manufactured (e.g., from free rise slabstock) to have a skinned surface or a cut, unskinned surface. Becausefoam has a cellular internal structure, when the foam is cut (e.g., diecut), an open cellular structure is exposed. The cut, open cellularstructure on the surface of the interface in contact with the skin hasdifferent performance characteristics compared to a skinned foam,particularly when used as a patient interface. For example, FIGS. 13-3and 13-4 illustrate a foam interface 80 having a cut, unskinned surfaceCS, and FIGS. 13-5 and 13-6 illustrates a foam interface 80 having askinned surface SS. As illustrated, the cut surface CS in FIGS. 13-3 and13-4 exposes the cellular structure of the foam, e.g., air bubbles andpin holes exposed. In contrast, the skinned surface SS in FIGS. 13-5 and13-6 conceals the cellular structure of the foam, e.g., smooth exteriorsurface with no air bubbles or pin-holes exposed.

2.3.1 Comfort

Specifically, a foam including a cut cellular structure (e.g., see FIGS.13-3 and 13-4) on surfaces that interface or contact with the patient'sskin has a different feel against the skin particularly compared tosilicone material, which is used almost without exception in theindustry. Also, the foam may be designed to have a very pleasing,comfortable tactile property that is not sticky or plastic in feel aswith silicone. A relationship exists between the cellular structure ofthe foam and its comfort against the patient's skin. Foam can beproduced to have a coarse to very fine-celled structure, and ahomogeneous or heterogeneous distribution of cell sizes. Theseproperties may be controlled through the manufacturing process. In apreferred embodiment, to maximize comfort against the patient's skin, aheterogeneous cell structure with a high content of fine sized cells maybe preferred.

2.3.2 Sealing and/or Gripping Function

The cut cellular surface (e.g., see FIGS. 13-3 and 13-4) of the foamprovides seal and/or grip. The foam may mechanically deform and engagethe patient's face, e.g., to provide seal, and may also grip the skinsufficiently so as to not dislodge (e.g., and lose seal) undermicro-movement (i.e., less than 1 mm). A cut cellular surface providesthis grip (e.g., friction grip) and may be improved in combination witha “wetter” feeling foam grade and a high degree of softness andvisco-elasticity in the foam grade. If the seal and/or grip isdislodged, it should regain its sealing and/or gripping propertieseasily, ideally without the need to reseat the patient interface on thepatient's face. An example of a preferred foam may be a very soft, low(isocyanate) index foam having a wet, sticky, and/or moist feeling totouch. The “stickiness” or “wetness” of the foam may allow slidingmovement of the foam along the patient's face without substantiallybreaking the seal, e.g., “crawling” seal. That is, the location of theseal may be shifted without losing contact with the patient's face andwithout losing substantial therapeutic pressure. The degree of grip orstickiness may be determined at least in part by surface tension (e.g.,coefficient of static friction) and/or the geometry of the cut surface(e.g., roughness).

2.4 Geometry

The foam interface 80 may have a geometry that is generally cradleshaped (i.e., curvature in one direction) or saddle shaped (i.e.,curvature in two directions). The interface may also have more than twodirections of curvature and complex curvature arrangements to address,match, or deliberately mismatch certain anatomical regions, depending onthe intended function of the geometry.

In the illustrated embodiment, the top surface of the foam interface 80provides a saddle shape that includes curvature in two directions thataids engagement of the patient's nose and its orifices. For example,curvature in a first direction (e.g., see front view of FIG. 15-1) isstructured to accommodate the anatomy that forms the alar angle of thepatient's nose, and curvature in a second direction (e.g., see side viewof FIG. 15-2) is structured to accommodate the anatomy that forms thenaso-labial angle of the patient's nose. The degree of curvature in bothfirst and second directions may be traded for extra compliance in theinterface mechanical properties in combination with extra interfacethickness (pile), e.g., the first and second curvature directions may beomitted for an interface that has sufficient softness and thickness tocomfortably and effectively hug engage and seal against the interfacing(e.g., nasal and facial) anatomy.

In an alternative embodiment, the mechanical properties of the foam maybe adjusted (e.g., softer) so that the interface will seal effectivelyusing a geometry that has a flat top surface (without curvature in thefirst and second directions described above).

In another embodiment, the curvature and shape of the foam may beprovided by the frame, backing, or other support structure that the foamis attached to.

Most sealing interfaces known in the art (especially siliconeinterfaces) are membranous. They are long, thin and flexible. The crosssection of the membrane has a high aspect ratio (length divided by widthor thickness) and hence, in combination with the softness of themembrane's material, it buckles easily along its length and bends easilyacross its width. Membranes typically do not compress along their lengthbecause they buckle easily and cannot support a compressive load in thedirection of its length (the material buckles before it compresses).This ability to buckle and bend gives a membrane type seal its abilityto conform and adapt to the varying anatomy of the face, particularlywhen presented (typically) tangentially to the face. Air pressure insidethe mask is known to provide a supporting reaction force to the membraneagainst the face.

The under-the-nose interface according to an aspect of the presentinvention is not a membrane and does not behave as such. Its crosssectional shape has a low aspect ratio and may be approximately square,rhomboid, rectangular or diamond in shape, as illustrated in FIGS. 15-1to 15-2. In other embodiments, the cross-section may be round,elliptical, or other more organic shapes depending on the possibilitiesafforded by the manufacturing process. Because the interfacecross-section is not long and thin, it does not behave as a membrane,but as a compression seal. So rather than relying primarily upon itsability to buckle to conform (tangentially) to the face likeconventional membrane seals, it relies upon its softness and compliancein a direction normal to the face to conform to the facial anatomy thatit is interfacing with. The subject interface is also not as reliantupon air pressure to support the interfacing structure and/or form aseal. The substantial thickness of the cross section in combination withits circular or annular profile means that it is predominantlyself-supporting, and as described previously the compressive force isincrementally a function of the pressurized air (air spring stiffness)where the foam sealing structure is air-permeable. The interface maydeform outwardly by the positive air pressure inside the mask chamber,but this deformation is a feature that may encourage the interface toengage the anatomy that it is interfacing with, e.g., the shape of theinterface may change under pressure to more closely approximate theshape of the patient's face.

2.5 Thickness

In an embodiment, the foam may have a thickness of about 5-20 mm, e.g.,15 mm, depending on the hardness and visco-elasticity of the foam, sothat the foam can deform with a hugging or wrapping effect under andaround the bottom of the patient's nose. In other embodiments, dependingon the number of layers of foam that make up the sealing interface andthe mechanical properties (e.g., hardness) of each layer, thethicknesses may vary accordingly, e.g., 5-50 mm, 10-30 mm, 14-20 mm. Forexample, the thickness of the skin-contacting layer of foam may be verysoft and very thin (e.g., 1-3 mm), and the conforming layer harder andthicker (5-20 mm). A harder and similarly thin or thinner (e.g., <1 mm)layer of foam may serve as a layer acting as an attachment mechanism.

The thickness of the foam may determine the mechanical compliance of theinterface in combination with the hardness of the foam. A softer foam incombination with a greater thickness can provide additional mechanicalcompliance and fit range, specifically when compared to silicone sealsknown in the art. The density, hardness, and thickness of the foam canbe controlled to achieve an interface that delivers a therapeuticpressure and a comfortable fit without fully compressing the providedfoam thickness. Due to the forgiving and compliant nature of the foam, adistinct advantage over other interfaces known in the art is that ofsizing consolidation, and even the possibility of providing aone-size-fits-all interface. That is, the softness and compliance of thematerial used in the interface may allow the interface component to fita much broader percentage of the population with the same or a reducednumber of sizes.

2.6 Orifice

In a preferred embodiment, the foam interface 80 includes a singleorifice 84 adapted to interface with both of the patient's nostrils(e.g., see FIGS. 13-1 to 13-2). Specifically, the interface compressesaround the openings of both left and right nostrils, e.g., eithersurrounding or partially occluding the nostrils, such that the orifice84 is in airpath communication with the nasal airways. In alternativeembodiments, the airpath communication may be via two or more orifices.In embodiments, the profile of the orifice 84 may have a generallyround, rectangular, rounded rectangular, triangular, elliptical, or ovalshape. However, other suitable orifice shapes are possible, e.g.,rounded triangular shape, rounded trapezoidal shape, rhomboid shape. Ina preferred embodiment, the orifice matches the shape of the externalprofile of the component, however the orifice profile and externalprofile may differ in shape considerably (e.g., the external profile maybe elliptical and the internal profile may be triangular). In analternative embodiment, the foam interface may include a block of foamwith no orifice and the permeability of the foam adjacent the airwayopenings may be sufficiently high so as to allow sufficient airflow tothe patient's nose.

2.7 Interfacing Path

In the illustrated embodiment, an external upper perimeter of the foaminterface 80 forms an interfacing path P (e.g., see FIGS. 13-1 to 13-2)that encompasses the inferior width of the nose, e.g., interfacesoutside of nose or external nares.

For example, the foam interface may be designed to engage the undersideof the nose. The geometry of the interface may be described genericallyas annular, having an inner and outer perimeter when observed in topview. The inner perimeter of the interface (which defines the orifice)may encompass the nostrils or partially occlude the nostrils makingalignment of the interface with the nostrils less critical. The areabetween the inner and outer perimeter may engage a broader area of theface in comparison to other interfaces known in the art (e.g., nasalprongs) to provide a more evenly distributed pressure and low force onthe face. The outer perimeter may sit within the inferior outline of thenose or give a close geometrical match to the width of the nose itself.In a preferred embodiment, the outer perimeter lies outside of theinferior outline of the nose to enhance the stability and snugness offit by allowing the interface to have a wrapping or cradling effectaround the width of the nose. This can aid the unobtrusive visualperception of the product when viewed from other than a first personperspective. Alternatively, the outer perimeter of the interface can bedesigned to lie outside the inferior outline of the nose, having ahugging or wrapping effect around the width of the nose. In the casewhere the outer perimeter of the interface is wider than the nose, thisarrangement may provide enhanced stability and snugness of theinterface. It may also allow for increased intuitiveness of fitting theinterface, especially in combination with a first direction curvature orV-shape (looking front-on at the face). The interface then features aself-alignment mechanism and intuitive location for the nose to besnuggly received.

In an embodiment, the foam interface is structured to sit under thenostrils and the angle of the interface or interfacing vector is morediagonally upward towards the crown of the head as opposed to directlybackwards and into the plane of the face, as is typical of theconventional over-the-nose interfaces.

For example, as shown in FIG. 16-1, the patient interface may include afirst loop LP1 (e.g., air delivery tubes) and a second loop LP2 (e.g.,back strap) connected to the first loop LP1 in use. As illustrated, thefirst loop LP1 passes along an underside of the patient's nose, alongthe cheek region, above the ears, and over the crown of the patient'shead to define a sealing force against the underside of the patient'snose. The second loop LP2 passes generally over the occipital bone todefine a headgear vector at an angle α between 40°-80° (e.g., 60°) withthe first loop LP1.

Another embodiment is shown in FIGS. 16-2 to 16-3 which schematicallyillustrate a frame 222 for supporting the foam interface that is adaptedto angle the interfacing vector more backwards. In combination withtubing having a rigidizing element, this allows the separation ofsealing forces and forces that stabilize the patient interface on thehead. More distinct control and adjustment of these forces is thereforeprovided as more of the stabilizing forces are supported above the toplip and on the cheek region of the patient. Thus, the interfacing vectoris less forcibly directed into the patient's nose, improving the comfortfor the patient. In another embodiment, the stabilizing forces may berelieved off the top lip and born more on the cheek region by providingload-bearing features on the headgear adjacent to the interface. Thisprovides greater stability of the mask system on the head without theneed to pull the very soft interface too tightly into the nose. The loadbearing features may form an integral part of the foam interfacecomponent and extend along the (e.g., inner) facial contacting surfacesof the headgear. They may also be permanently or removably fixed to theheadgear separate to the interface.

Further, the surface area provided by the frame may be smaller (e.g.,narrower width across the face, narrower diameter), which may provide asmaller reaction force into the patient's face to achieve an effectiveinterface.

2.8 Breathability

According to an embodiment of the present invention, the foam interfacemay include a breathable or permeable foam (e.g., based on a cut surfaceand/or the elimination of skin) that allows a deliberate amount ofairflow both through the interface material (e.g., foam bulk structure)and between the interface and the patient's skin (e.g., cut surface offoam). Patient comfort and compliance is enhanced by decreasing theaccumulation of sweat around the face, keeping the skin drier, andmoderating the temperature of the skin in contact with and around theinterface. Ideally, the airflow is designed to be less than an amountthat causes excessive drying of the skin and cooling of the anatomyaround the interface when worn on the face.

That is, the foam's construction provides a breathable interface suchthat condensation buildup and associated irritation can be avoided atthe contact interface between the patient and interface. The foamprovides “a leaky” interface (e.g., measured by a percentage of ventflow) with intentional/controllable leak through the foamstructure/matrix that helps to create air circulation to keep thecontact surfaces relatively dry and comfortable (e.g., about 10% of ventflow, 30-40% of vent flow). The amount of leak provided by the foam maydepend on comfort, drying skin, and/or annoyance, for example.

In an embodiment, the foam interface may be constructed to leak withinpredictable and predetermined limits and physical locations, e.g., varyair flow permeability or breathability around the outer perimeter of theinterface. Also, the material of the foam may be selected to managemoisture, e.g., avoid moisture buildup in some regions and encouragemoisture in other regions, e.g., near nose for humidification.Hydrophobic and hydrophilic (e.g., moisture wicking) materials (ortreatments resulting in similar properties) are some options. Moisturewicking foam adapted to “pull” moisture or sweat from the patient's skinmay decrease skin breakdown, pressure sores, and/or ulceration.

The foam may be designed to feature different degrees of airpermeability through the bulk of the foam and through the surface of thefoam. The foam may be impermeable through its body and permeable just atits interfacing surface. Conversely, the foam may be permeable throughits body and impermeable at its interfacing surface, though resulting indifferent sealing characteristics. For example, this could allowbreathability to be achieved while achieving alternative interfacingand/or sealing characteristics to the cut-cellular structured foaminterface described herein. The foam may also be structured to beimpermeable throughout, or impermeable in specific locations whereairflow permeability is to be avoided, e.g., into the eyes.

The breathable interface may improve the dynamic interfacing performance(i.e., the ability to withstand macro-movement from a patient rollingaround in bed and maintain an interface) over conventional interfacingmaterials. This is achieved because a small amount of airflow is alreadyflowing between the interface surface and the patient's skin and thereis less consequence to the interfacing mechanism when it is subjected tomacro-movement compared to a conventional silicone seal. Silicone reliespartially on its ability to “stick” to the patient's skin to provide astable dynamic seal. Thus, when the silicone seal is moved tangentiallyalong the skin surface, it is forced to buckle and completely detachfrom the skin and be reseated normally to the face to regain itsgeometrical form that it was designed to sit in to seal. That is, thesilicone seal will provide an abrupt leak upon shifting ormacro-movement that requires reseating of the interface, whereas thebreathable foam interface provides an interface that can regain itsinterfacing properties easily without the need to reseat the foaminterface on the patient's face to recover from its buckled geometry(e.g., from movement of the face relative to the interface). This isalso an effect of having an interface that does not rely on membranemechanics to interface and/or seal. The width of the cross-section ofthe interface may typically be an order of magnitude larger than amembrane thickness (preferably 5-12 mm and even more preferably 8-10 mm,as compared to 0.35-1.0 mm). The larger width may allow for theinterface to engage with the patient's face over a larger area, and assuch may not be as sensitive to a local disruption in the interfacingmechanism due to movement or surface irregularity on the patient's face.In addition, the cut surface of the foam interface provides lowertension transfer across the surface when it is compressed into the face,which is an improvement in dynamic sealing performance over siliconemembrane seals which are susceptible to leakage due to creasing whenthey move on the face.

In an alternative embodiment, the foam interface may have a skinnedsurface, and the skinned surface may be permeable to provide similareffects as a foam interface having a cut, unskinned surface. Forexample, the skinned surface may in the form of a breathablepolyurethane skin, a membrane that allows permeability, a texturedsurface, a spray-on porous coating, a perforated skin, and/or a textile.In another example, as shown in FIG. 13-8, the foam interface 80 mayhave a skinned surface SS, and a vent 81 may extend from the foaminterior to atmosphere to allow permeability.

FIG. 14-2 is a graph that illustrates properties of a foam interfaceaccording to an embodiment of the present invention. As illustrated, thefoam interface may be structured such that leak decreases as forceapplied to the interface (both in compression and extension) isincreased. Also, the disruption to leak flow with movement away from thepatient's face is minimal.

2.9 Compliance

The foam interface has a (mechanically) compliant nature that allows itto accommodate a much larger range of facial geometry compared tointerfaces made of silicone and other materials known in the art. Thisarrangement allows for the possibility of consolidating the number ofsizes required to fit a patient population, e.g., potentially aone-size-fits-all interface.

Because of the mechanical compliance of the bulk material, the foam sealconforms readily to a larger range of facial shapes as compared to anon-foam seal.

One way that compliance can be quantified is by measuring to what extentthe bulk material wraps around a cylinder of a given diameter. Morespecifically, the angle the bulk material wraps around the cylinder canbe measured with respect to the longitudinal axis of the cylinder.

A preferred foam according to an embodiment of the present invention hasa cut or unskinned patient contacting surface and a thickness of between8 and 14 mm and has a density of between 40 and 70 kg/cubic meter.

That is, the foam interface may provide superior mechanical compliance,and this combined with the fact that the region of interfacing is lesscomplex and has less magnitude of anthropometric variation (e.g.,compared to conventional nasal and full face interfaces) gives theinterface superior fitting qualities. The foam can deform to theappropriate size and shape (e.g., localized deformation) withoutcompromising the interface (e.g., buckling, creasing) and without addingdiscomfort to the patient (e.g., lower and more even pressure on theface). In addition, the highly compliant foam fits and interfaces with abroader range of population for a given geometry (e.g., size),especially compared to silicone interfaces. Further, the mechanicalcompliance of the foam interface can make the patient interface designless reliant on strap tension from headgear. In an embodiment, thepatient interface may be fitted to the patient's face by fitting the airdelivery and stabilizing system (e.g., headgear) and then allowing theinterface to find its way to the patient's nose without the need forrefined adjustments. That is, the foam interface better accommodatesimprecise fitting.

The compliant nature of the foam also allows the foam to quickly adaptto the patient's face, (e.g., upon initial fitting or when the patientmoves or rolls around during sleep), without compromising the interfaceand without adding discomfort to the patient. That is, the foam providesgreater tolerance to misalignment.

2.10 Warming

The foam interface may provide a warming sensation to the patient'snares upon exhalation, e.g., similar to breathing into a blanket on acold night. This arrangement reduces the “frozen nose” effectexperienced by some users of nasal prong or nasal pillow interfaces. Inan embodiment, the foam interface may include extended side portionsthat extend along sides of the patient's face, e.g., along upper cheekregions between the air delivery tubes and the patient's cheeks near orextending from the mouth, to provide the warming sensation to otherareas of the patient's face.

2.11 Layers

In an embodiment, the interfacing structure may include a soft foamattached to a stiffer structure, e.g., 40 Shore A silicone shell with awall thickness of approximately 1.5 mm such as the cylindrical supportdescribed in U.S. patent application Ser. No. 10/781,929, the entiretyof which is incorporated herein by reference.

In another embodiment, the interfacing structure may include multiplelayers with each layer providing a certain function. For example, FIG.17-1 schematically illustrates an interfacing structure including fourfunctional layers. The first layer L1 represents a skin-contacting layerthat is structured to provide a comfortable seal against the skin of thepatient's face and/or nose. The second layer L2 represents a conforminglayer that is structured to easily conform to the patient's nasalanatomy. The third layer L3 represents a form holding layer that isstructured to support the interface to hold its overall form (since thesoftness of the L1 and L2 layers may not be sufficiently self-supportingunder loading conditions). The fourth layer L4 represents aretention/attachment layer that is structured to retain/attach theinterfacing structure to the patient interface, e.g., frame, shell.

For simplicity, all functions would be provided by as few physicallayers or components as possible. For example, the functionality of theskin contacting layer L1 and the conforming layer L2 may be provided byone material that includes both a comfortable feel on the skin andsuitable plush compressive properties to conform around the underside ofthe nose. In another example, the reinforcing functionality of the L3layer and the attachment functionality of the L4 layer may be providedby the (L4) attachment mechanism, and/or by the substrate (e.g.,adhesive) used to join the functional layers together.

In an embodiment, such as that shown in FIGS. 13-1 and 13-2, the foaminterface 80 with a cut cellular structure may provide the functionalityof the first and second layers L1, L2, the cylindrical support 82 (e.g.,made of silicone) may provide the functionality of the third layer L3,and a loop material for attachment to a frame may provide thefunctionality of the fourth layer L4 (described below).

In another embodiment, the L3 form holding layer may include a materialthat is malleable (e.g., aluminum wire) so that the interface may bemanually deformed into a more effective and comfortable geometry.

In alternative embodiments, the first or skin contacting layer L1 may beflocked or covered with a textile (or other suitable breathablematerials), e.g., for comfort, grip, alternative wicking properties,and/or alternative air permeability.

2.12 Attachment Mechanism

In the illustrated embodiment, the interfacing structure 20 is aseparate component from the air delivery and stabilizing system 30.Therefore, an attachment mechanism is provided to secure (e.g.,removably secure) the interfacing structure to the air delivery andstabilizing system. As noted above, a portion of the attachmentmechanism may form a retention layer L4 of the interfacing structure.

2.12.1 General Physical Requirements

The interface component is typically a separate component to the rest ofthe patient interface. This is due to many reasons including: theinterface geometry is usually complex and difficult to manufacture incombination with other components of the patient interface; interfacesusually need to accommodate a large anthropometric variation and as suchseveral interchangeable interface sizes exist to cover the full range ofvariation; the interface may require washing many times during its lifeand having it removable allows for a more thorough wash and makescleaning an easier task; and/or interface has a replacement frequencygreater than that of the rest of the patient interface and needs to beremovable to be replaced.

The attachment mechanism is structured such that all assembly anddisassembly tasks performed by the patient should be as easy aspossible, particularly considering the potentially varied ages andintellectual and physical competencies of the patient.

For ease of assembly, elements of orientation, alignment, and force areconsidered in the design. In an embodiment, the interface includes aslittle asymmetry as possible (e.g., allowing functionally correctattachment in as many different (e.g., two) orientations as possible),intuitive cues as to the method of attachment (e.g., self-aligning orself-orienting), a size, shape, and texture that is not difficult tohandle (e.g., requiring minimal dexterity), tolerance to misalignment,as little force as possible to assemble, and/or as little force aspossible to disassemble. A force feedback from a mechanism usually canindicate to a user that assembly has occurred and is correct. Whilerequiring as little force as possible to assemble, a correct assemblyshould be evident to the patient.

If assembly force is very low, disassembly force should be higher thanthe assembly force to ensure that disassembly does not occurinadvertently. Disassembly force should not be too high as to riskdamage to the interface component or other components of the patientinterface.

The attachment of the interface to the frame of the patient interfaceshould have no air leak (e.g., sealed) or a small, known amount of airleak over the treatment pressure range.

In an embodiment, as shown in FIG. 17-2, the foam interface 80 may beprovided to a base B adapted to retain the foam interface to a frame F.As illustrated, the base B is sufficiently longer than an inlet to theframe (e.g., length D of base is longer than length d of frame inlet)such that the base B is resiliently squeezed and/or simply manipulatedthrough the inlet and into a slot S provided in the frame F where it isretained in an operative position.

In another embodiment, as shown in FIGS. 17-3A to 17-3C, a mechanicalinterference type attachment mechanism may removably attach theinterfacing structure to the patient interface. As illustrated, a base B(e.g. stiff laminate) may be provided on the under side of theinterfacing structure (e.g., in the form of a foam interface 180) and anattachment structure AT may be provided to the frame of the patientinterface.

As illustrated, a hook portion HP extends from the inner edge of theattachment structure AT. In use, the base B is resiliently stretchedand/or simply manipulated over the hook portion HP where it is retainedin an operative position, e.g., with a mechanical interference fit. Asshown in FIG. 17-3C, the free end 185 of the hook portion HP overhangsthe inner edge of the base B to prevent inadvertent removal.

Also, the free end 185 of the hook portion HP provides an internal lipthat is pressed against the foam interface 180 to provide a seal. Thus,the base B and attachment structure AT provide both attachment and acircumferential seal between the interfacing structure and the frame.

In the illustrated embodiment, the base B and attachment structure ATeach have a generally planar configuration and the profile of the base Band attachment structure AT is substantially similar to the profile ofthe under side of the interfacing structure, e.g., elongated orelliptical ring shape.

As illustrated, the outer edges of the base B and attachment structureAT substantially align with outer edges of the under side of the foaminterface 180. The inner edges of the attachment structure AT may beslightly external to inner edges of the under side of the foam interface180, e.g., due to the hook portion HP.

However, other suitable perimeter boundaries are possible. For example,the coverage of the base B and attachment structure AT on the under sideof the interfacing structure may be matched, internal, or external tothe inner and outer edges of the under side geometry profile. In anembodiment, the base and attachment structure may be internal to theouter edge of the under side to prevent contact of the base andattachment structure with the patient's top lip in use.

The mechanical interference type attachment mechanism may have othersuitable arrangements. For example, the mechanical interference typeattachment mechanism may include: an internal lip with a sleeve section;an internal lip with angle section; an external lip with a singlereinforcement layer; an external lip with a double reinforcement layer;a push-in fit with a single foam layer; or a push-in fit with a doublefoam layer.

In yet another embodiment, an adhesive type attachment mechanism mayremovably attach the interfacing structure to the patient interface. Forexample, an adhesive (e.g. pressure sensitive adhesive (PSA)) may beprovided on the under side of the interfacing structure (e.g., in theform of a foam interface) that allows the interfacing structure to beremovably attached to the frame of the patient interface.

In an embodiment, the under side and adhesive (e.g., PSA) providethereto may have a generally planar configuration. In anotherembodiment, the under side and adhesive may provide a curvature along afirst direction. In another exemplary embodiment, the base and adhesivemay provide curvature along two or more directions, e.g., saddle shapeover centering action.

The coverage of the adhesive on the under side of the interfacingstructure may be matched, internal, or external to the inner and outeredges of the under side geometry profile. In an embodiment, the adhesivemay be matched to the edges of the profile for ease of manufacture. Inanother embodiment, the adhesive may be internal to the outer edge ofthe under side to prevent contact of the adhesive with the patient's toplip in use.

In another embodiment, the attachment mechanism may be structured tomanipulate the life span of the interface, e.g., attachment mechanismfails at a predetermined time and therefore requires replacement of theinterface.

In another embodiment, no significant attachment mechanism may beprovided as the interface is sandwiched between the frame and thepatient's face in use.

2.12.2 Hook and Loop Material

In an embodiment, the attachment mechanism may be in the form of a hookand loop material, e.g., Velcro™. For example, the hook material may beprovided on the frame and the loop material, e.g., UnBroken Loop (UBL),may be provided on the under side or base of the interfacing structure.For example, the loop material may be provided on the underside of thecylindrical support 82, e.g., by an adhesive.

This arrangement of the hook and loop material may be reversed, but inthe context of an interface that has a high replacement frequency, it ispreferred that the less durable side of the hook and loop material isattached to the interfacing structure, i.e., the loop material. A hookand loop style attachment mechanism allows for an intuitive assemblythat requires very little force for assembly/disassembly.

A hook and loop interface typically is not airtight. Therefore, a hookand loop interface according to an embodiment of the present inventionmay include a small, known amount of leak that is repeatable within adefined range between assembly actions.

In an alternative embodiment, the attachment and interface-to-framesealing functions may be performed separately. For example, a hook andloop interface may be used to provide the attachment, and a softdeformable closed loop linear interface may be used to provide thesealing. The hook and loop interface provides attachment between theinterfacing structure and the frame and in doing so provides a normalforce that presses the loop material onto a soft circumferential seal onthe opposing side of the interface-to-frame arrangement. The interfacingstructure may lie either on or adjacent to the hook material provided tothe frame.

In another embodiment, instead of the interface or seal pressing againstthe loop material, the loop material may have a matching smoothrubber/plastic surface for the interfacing or sealing to work against.

In an exemplary embodiment, the interfacing structure may be formed byproviding a sheet of foam material (e.g., slabstock or block of foammaterial (e.g., 1 m×0.5 m×2 m block)), laminating or otherwise attachinghook material to the foam sheet, and die cutting the foam sheet to formthe desired shape of the interfacing structure.

FIGS. 17-4A to 17-4C illustrate another embodiment of a hook and looptype attachment mechanism (e.g., Velcro™) structured to removably attachthe interfacing structure to the patient interface. As illustrated, aloop material LP may be provided on the under side of the interfacingstructure (e.g., in the form of a foam interface 180) and a hookmaterial HK may be provided to the frame of the patient interface. Itshould be appreciated that the arrangement of the hook and loop materialmay be reversed.

As illustrated, a sealing lip SL extends from the inner edge of the hookmaterial HK. In use, the hook and loop materials are removably engagedwith one another, which presses the loop material LP against the sealinglip SL to provide a seal. Thus, the hook and loop type attachmentmechanism provides attachment between the interfacing structure and theframe, and the sealing lip SL is deformable to provide a circumferentialseal between the interfacing structure and the frame.

In the illustrated embodiment, the hook and loop material HK, LP eachhave a generally planar configuration and the profile of the hook andloop material HK, LP is substantially similar to the profile of theunder side of the interfacing structure, e.g., elongated or ellipticalring shape.

As illustrated, the inner and outer edges of the hook and loop materialsubstantially align with inner and outer edges of the under side of thefoam interface 180. That is, the perimeter boundaries of the hook andloop material may be matched to the edges of the under side geometryprofile of the interface, e.g., for ease of manufacture.

However, other suitable perimeter boundaries are possible. For example,the coverage of the hook and loop material on the under side of theinterfacing structure may be matched, internal, or external to the innerand outer edges of the under side geometry profile. In an embodiment,the hook and loop material may be internal to the outer edge of theunder side to prevent contact of the hook and loop material with thepatient's top lip in use.

The hook and loop type attachment mechanism may have other suitablearrangements. For example, the hook and loop materials may provide aplanar configuration such as that described above, but without a sealinglip. In another exemplary embodiment, the hook and loop materials mayprovide a curvature along a first direction. In another exemplaryembodiment, the hook and loop materials may provide a curvature along afirst direction and a sealing lip such as that described above. In yetanother exemplary embodiment, the hook and loop materials may providecurvature along two or more directions, e.g., saddle shape overcentering action.

2.12.3 Snap-Over Low Retention

FIGS. 18-1 to 18-3 illustrate a method of joining an under-the-nose foaminterface 380 to a frame 322 according to another embodiment of thepresent invention. In this embodiment, the under-the-nose interface 380includes structure that allows it to be attached to the frame 322 with asnap-over fit, and the connection relies on the friction and/ormechanical interlock between the under-the-nose interface 380 and frame322 for its strength. The resultant joint would have limited strength,however the location of the joint allows the force between the patientand the frame to assist in strengthening the joint.

As shown in FIGS. 18-1 and 18-2, the frame 322 includes a generallytubular structure that is curved along its length so that it can followthe contours and/or conform to the shape of the patient's face in use.As shown in FIGS. 18-2 and 18-3, the under-the-nose interface 380 isstructured so that it can be attached to the frame 322 with a snap-overfit. Specifically, the back side of the under-the-nose interface 380includes a groove 387 along its longitudinal axis that is adapted toreceive a portion of the tubular frame 322 therein. One or more surfacesand/or edges of the groove 387 are adapted to engage the frame 322 witha friction and/or mechanical interlock fit. Also, each end of theunder-the-nose interface 380 includes an arcuate cutout 389 that isadapted to receive a respective end portion of the frame 322 as itcurves along its length.

2.12.4 Snap-Over with PSA

In another embodiment, an under-the-nose interface or foam interface maybe joined to a frame by a pressure sensitive adhesive (PSA). FIGS. 19-1to 19-3 are sequential views illustrating a manufacturing process forapplying PSA to the back of an under-the-nose interface according to anembodiment of the present invention. FIG. 19-1 illustrates an untreatedunder-the-nose interface 480, FIG. 19-2 illustrates an under-the-noseinterface 480 after a PSA 485 has been applied, and FIG. 19-3illustrates the finished sub-assembly after a removable backing 486 hasbeen applied to the PSA 485 on the under-the-nose interface 480.

The under-the-nose interface 480 would be assembled in a similar manneras that shown in FIGS. 18-1 to 18-3, e.g., snap-over fit. In contrast,the backing 486 is removed from the under-the-nose interface 480 beforeassembly in order to reveal the PSA 485. The resultant joint will haveincreased joint strength with the PSA 485. When choosing a PSA, the PSAshould be configured such that it adheres better to the under-the-noseinterface than to the frame. That is, the cohesive strength of the PSAis preferably higher than the adhesive strength. This arrangement allowsthe PSA to remain on the under-the-nose interface and not on the framewhen the under-the-nose interface is pulled off from the frame, e.g.,for cleaning or replacement.

2.12.5 Snap-Over with Groove or Undercut

FIGS. 20-1 to 20-3 illustrate a method of joining an under-the-noseinterface or foam interface 580 to a frame 522 according to anotherembodiment of the present invention. In this embodiment, theunder-the-nose interface 580 includes a groove or undercut 595 onopposing sides thereof that is adapted to mate or interlock withrespective protrusions 596 provided on the frame 522, e.g., with asnap-fit. The resultant joint will have increased joint strength withrespect to that shown in FIGS. 18-1 to 18-3 for example.

In an alternative embodiment, the under-the-nose interface may provide acomposite snap-over arrangement. For example, FIGS. 20-4 to 20-7 aresequential views illustrating a manufacturing process for forming acomposite under-the-nose interface according to an embodiment of thepresent invention. In FIG. 20-4, a visco-elastic foam portion 1291 isformed having a first side that provides a patient interface and asecond side that provides spaced apart platforms 1293. In FIG. 20-5,connecting portions 1297 are formed each having a groove or undercut1295. The connecting portions 1297 are constructed from a materialhaving a lot more resilience and structure than the visco-elastic foamportion 1291, e.g., high density foam, TPE, TP. In FIG. 20-6, anadhesive 1285, e.g., hot melt glue, is applied to each of the platforms1293 of the foam portion 1291. Then, as shown in FIG. 20-7, theconnecting portions 1297 are attached to respective platforms 1293 ofthe foam portion 1291 via the adhesive 1285 to assemble the compositeunder-the-nose interface 1280. In use, the composite under-the-noseinterface 1280 may be attached to a frame such as that described inFIGS. 20-1 to 20-3, e.g., groove or undercut 1295 interlocks withrespective protrusions provided on the frame. The compositeunder-the-nose interface 1280 provides connecting portions 1297 that arestructured to provide a higher joint strength than visco-elastic foamalone. It should be appreciated that other suitable manufacturingprocesses may be used to create a composite under-the-nose interface.

In yet another embodiment, the attachment mechanism may be structured toallow the foam of the interface to be received into a receiving channelin the frame or shell. The seal and retention in this case relies uponthe interference fit between the foam and the channel in the frame orshell. The very soft interfacing foam is preferably laminated orotherwise joined to a harder and more dense foam (or other structure)that results in a greater interference force when engaged with thechannel.

In another embodiment, the attachment mechanism can be achieved througha rigid or semi-rigid component adhered to the underside of the softinterfacing foam. The rigid/semi-rigid component may be configured toprovide a number of mechanical interference fits, e.g., clippedinto/onto frame.

2.12.6 Magnetic Arrangement

In an alternative embodiment, the attachment mechanism may include amagnetic arrangement to magnetically couple the frame and theinterfacing structure.

2.13 Structural Compliance

2.13.1 Background

The topography around the nose has steep gradients with sharptransitions between these gradients. For an interface to be mosteffective, it needs to be flush with all surfaces to achieve aninterface, e.g., seal. A low resilience structure would allow thegreatest comfort while still achieving an interface, e.g., textileinterface. However, textile interfaces are typically very thin (e.g.,less then 2 mm thick) and cannot in themselves offer the requiredproperties to add compliance. In order for a textile interface toconform to the patient's face, a support structure is required. However,a support structure is not limited to textile interfaces, i.e., foam andsilicone interfaces to name a few could benefit from a support structureas well.

2.13.2 Flexible Frame

In an embodiment, the interface may be mounted on a frame made from aflexible material, e.g., injection molded silicone frame. Each end ofthe frame would be attached to a respective tube 42. When pulled againstthe patient's face, the flexible frame can conform to the patient'sface, e.g., wrap around the patient's nose without pinching.

The frame may be constructed of materials having different stiffnesses.If the frame is constructed of silicone, this arrangement may beachieved by simply using silicones with different Shore Hardnesses.

For example, FIGS. 21-1 to 21-3 illustrate a frame 622 for supporting anunder-the-nose interface 680 and vent 627 according to an embodiment ofthe present invention. As best shown in FIGS. 21-2 and 21-3, the centralportion C of the frame 622 (shown in darker shading) is stiffer than theside portions S of the frame 622.

This arrangement results in side portions S having more flexibility thanthe center portion C of the frame 622. As shown in FIG. 21-3, as a forceapplied to the frame 622 is increased, the deflection of the sideportions S is more substantial than that in the center portion C. As aresult, the frame 622 will not pinch the patient's nose and the centerportion C will remain relatively straight to prevent the interface fromoccluding the nostrils. In addition, the stiffer center portion Censures that the conduit in front on the patient's nose is maintainedopen in use.

FIG. 22-1 illustrates a flexible frame 722 according to anotherembodiment of the present invention. In this embodiment, the frame 722may be a molded foam conduit including openings 722.1 and 722.2 adaptedto engage an under-the-nose interface, e.g., replaceable foamunder-the-nose interface, and vent. The ends of the frame 722 may attachto respective tubes 42 in any suitable manner.

2.13.3 Flexible Frame with Spring Element

In another embodiment, a flexible frame such as those described abovemay include a spring element to increase comfort. For example, FIG. 23-1illustrates a flexible frame 822 including a spring element 828 and aninterface 880 provided to the frame 822. The spring element 828 may be athermoplastic elastomer (TPE) or a metal (e.g., Polycarb, Nitinol,etc.). In the illustrated embodiment, the spring element 828 is attachedhorizontally along the frame 822. However, other suitable arrangementsare possible. In use, the spring element 828 is structured to counteractthe force provided by the air delivery and stabilizing system 30, e.g.,tubes 42. The spring element will effectively increase the radius of theframe 822 when attached to the patient.

In an embodiment, the spring element may be a variable spring elementthat varies its k values across its length, e.g., see graph of FIG.23-2. As illustrated, the spring element may have a k that resembles ageneral bell curve arrangement such that the middle of the springelement is relatively stiff and the ends of the spring element arerelatively loose. This arrangement may be advantageous as the curvatureof the patient could be better matched. For example, if the interfacewas an under the nose type interface, a relatively stiff spring may beprovided in the middle of the frame and then a loosening spring may beprovided as the frame moves away from the center of the nares.

To add further compliance, a low resilience foam may be added betweenthe spring element and the interface. For example, FIG. 23-3 illustratesan interface 980 provided to a frame having a low resilience foam 956, amedium density foam 957, and spring elements 929, e.g., constructed ofNitinol.

2.14 Venting

In an embodiment, a breathable foam interface may provide the necessaryvolume of CO₂ washout or venting, which may obviate the need forseparate CO₂ washout vents. In addition, the breathable foam interfacemay provide a vent silencing or diffusing feature. Thus, the breathablefoam interface may provide a single component with dual purposes, e.g.,sealing and venting. However, CO₂ vent holes may be used in conjunctionwith a foam interface, e.g., because condensation may block one or morebreathable portions of the breathable foam interface. The air ventingfrom the CO₂ vent holes may pass through the foam as a means ofdiffusing and reducing noise from the stream of venting air.

For example, the frame or support that supports the foam interface mayinclude one or more vent holes for CO₂ washout, e.g., see FIGS. 1-8,2-1, and 18-1.

Also, FIG. 24-1 illustrates a foam interface 1080 including a rigidizer1098 that provides venting. The rigidizer 1098 may be in the form of arigid/semi-rigid backing piece including holes 1099 for venting. Asillustrated, the foam interface 1080 includes a “boomerang” shape. Thesemi-porous nature of the foam and the extended arms of the “boomerang”shape allows the patient's skin to breathe under the foam, as the foamhas a very small and diffuse flow of air constantly coming out of thefoam from the orifice outwards.

Further, in an alternative embodiment, the frame or support thatsupports the foam interface may include one or more supplemental ports,e.g., to provide supplemental oxygen and/or collect pressure/humiditydata.

2.15 Alternative Interfacing Arrangements

It should be appreciated that the interfacing structure may have otherinterfacing arrangements. That is, the foam interface type is merelyexemplary, and the foam interface may be adapted for use with othersuitable interface types, e.g., over-the-nose interface, nasal cushion,mouth, full-face, nasal prongs, etc. For example, FIG. 25-1 illustratesan embodiment of a patient interface 1110 including an under-the-noseinterface 1180 and a mouth interface 1181, e.g., constructed of foam, tointerface or seal with the patient's mouth in use.

2.16 Foamed Silicone

In lieu of and/or in addition to using visco-elastic foam (e.g.,polyurethane) as discussed above, various components of the patientinterface may be constructed at least in part from a silicone that isfoamed, i.e. foamed silicone. That is, one or more portions of acomponent may be constructed from foamed silicone or an entire componentmay be constructed from foamed silicone.

For example, a forehead pad for a forehead support of a patientinterface includes a stalk or connector adapted to connect the foreheadpad to a frame and a patient-contacting pad portion adapted to contactthe patient's forehead. In an embodiment, the stalk may be constructedfrom a non-foamed silicone (e.g., LSR) and the patient-contacting padportion may be constructed from a foamed silicone.

In other examples, the cushion of the patient interface and/or conduitsconnected to the patient interface may be partly or wholly constructedfrom foamed silicone.

The foamed silicone can provide respective components with different“feels” and/or different connection properties.

For example, foamed silicone may provide one or more of the followingproperties: lighter; appealing texture, comfort; uses less material;opaque or translucent; cleanable (e.g., if there are a sufficiently highpercentage of closed cells) to make the component longer lasting andwith a lower replacement frequency; softer at a given thickness ordurometer; lower extensibility and tear resistance; surface propertiesmay be altered (e.g., with a skin); impermeable to air/biologicalmatter; permanence of sealing properties with age (e.g., oil/greaseabsorbance); and/or surface breathable but body impermeable.

3. Application to Known Masks

One or more aspects or features of the present invention may be adaptedfor use and/or incorporated into embodiments and/or components of knownmasks, as would be apparent to those of ordinary skill in the art.

3.1 Respironics' ComfortCurve™

FIG. 26-1 illustrates a known mask 1500 commercially sold by RespironicsInc. under the name of ComfortCurve™ and one or more portions of themask are described in Australian Application No. AU 2005100738,published Nov. 24, 2005. As illustrated, the mask 1500 includes a frame1502, a cushion 1504 provided to the frame 1502 and adapted to form aseal with the patient's nose in use, cheek pads 1506 provided to theframe 1502 to support the cushion 1504 in use, inlet tubes 1508 providedto the frame 1502 and adapted to deliver breathable gas to the patient,and headgear 1505 removably attached to the frame 1502 to maintain themask 1500 in a desired position on the patient's face.

3.1.0 Improvements/Alternative Arrangements

The following embodiments describe improvements and/or alternativearrangements of Respironics' ComfortCurve™ mask to enhance respiratorytherapy.

3.1.1 Foam Seal

The ComfortCurve™ mask includes a cushion constructed of a siliconematerial. In an alternative embodiment, as shown in FIG. 26-2, thecushion may be a foam cushion 1504F constructed of a foam material F.The foam material F may include one or more of the foam propertiesdescribed above, e.g., visco-elastic, un-skinned, etc.

In such embodiment, the frame attachment mechanism or clip 1507 may bemaintained as a base substrate and the foam material F may be attachedto the clip 1507. This arrangement allows removable attachment of thefoam cushion to the existing frame of the ComfortCurve™ mask.

In an embodiment, as shown in FIG. 26-3, the foam cushion 1504F mayextend along side portions of the frame 1502 (e.g., in place of thecheek pads 1506) so that the foam material F may wrap around thepatient's nose and/or conform to the patient's face when the frame 1502is pulled against the patient's face in use.

In an embodiment, the foam cushion 1504F may include multiple layers,e.g., a first layer constructed of a high density foam and a secondlayer constructed of a more compliant foam adapted to engage thepatient's face.

In another embodiment, as shown in FIG. 26-4, the ComfortCurve™ cushion1504 may be provided with a foam or fabric layer FL on a contact surfaceadapted to engage the patient's face. The foam or fabric layer FL may beprovided to the cushion in any suitable manner, e.g., spray-on foam likeflocking, fabric adhered to cushion, etc. The foam or fabric layer FLmay improve comfort, feel, and/or softness, and may provide a moisturewicking feature.

3.1.2 Conduit Headgear

The ComfortCurve™ mask includes headgear constructed of a fabric-typematerial to maintain the mask in a desired position on the patient'sface. In an alternative embodiment, as shown in FIG. 26-5, the headgearmay be replaced or combined with collapsible conduits 1540 adapted todeliver breathable gas and stabilize the cushion interface on thepatient's face. The conduits 1540 may include one or more of the tubeproperties described above, e.g., partially or fully collapsible,cross-sectional contour that blends into the patient's face, etc.,and/or the conduits 1540 may include a rigidizer.

3.1.3 Tube Routing

In another embodiment, as shown in FIG. 26-6, the inlet tubes 1508 maybe routed through the headgear 1505, e.g., up towards the top of thepatient's head, rather than hang downwardly from the frame.

In such embodiment, a support member may be provided to the headgear toimprove stability. For example, a wire member (e.g., magnesium wire) maybe provided to the headgear straps that extend from the frame to top ofthe patient's head.

3.1.4 Soft Material on Headgear Strap

In another embodiment, as shown in FIG. 26-7, one or more straps of theheadgear 1505 may include a relatively soft cover, sock, or pad 1509,e.g., constructed of foam or gel, to improve comfort.

3.1.5 Inlet Tubes Attached to Cheek Pads

In another embodiment, as shown in FIG. 26-8, the cheek pads 1506 may beinflatable and the inlet tubes 1508 may be attached or otherwisecommunicated to the cheek pads 1506 to inflate the cheek pads 1506 inuse. Such an arrangement may be adapted for use with the conduitheadgear described above.

Also, in an embodiment, the cheek pads may be in fluid communicationwith the cushion such that air may pass from the inlet tubes and intoboth the cushion cavity and cheek pads.

3.1.6 Inlet Tubing Along Inside of Frame/Headgear

In another embodiment, the inlet tubes may extend along an inner side ofthe frame (e.g., adjacent the patient's face) and/or the headgear,rather than along the outer side of the patient's face.

3.1.7 Accommodate Alar and Naso-Labial Angle

In another embodiment, the cushion may be structured to accommodate thealar and naso-labial angle of the patient's nose.

3.1.8 Eliminate Cheek Pads

In another embodiment, the cheek pads may be eliminated. In suchembodiment, as shown in FIG. 26-9, a yoke or rigidizer 1511 may beprovided one or more straps of the headgear 1505 to improve stability.For example, the rigidizer may be structured similar to that provided onResMed's VISTA™ and SWIFT™ masks, e.g., see U.S. Pat. No. 6,907,882 andU.S. patent application Ser. No. 10/781,929, filed Feb. 20, 2004, eachof which is incorporated herein by reference in its entirety.

In an embodiment, the rigidizer 1511, frame 1502, and inlet ports 1514associated with inlet tubes 1508 may be integrally formed as a one-piecestructure.

In another embodiment, the cheek pads may be eliminated and the framemay be extended to improve stability. For example, as shown in FIG.26-10, the frame may include extended side portions 1513 that extendalong the sides of the patient's head and taper/thin out towards thepatient's temple. Ends of the side portions 1513 may include suitablestructure for attachment to respective headgear straps.

3.2 Respironics OptiLife™

FIG. 27-1 illustrates another known mask 1600 commercially sold byRespironics under the name of OptiLife™. As illustrated, the mask 1600includes a frame 1602, nasal pillows 1604 provided to the frame 1602 andadapted to form a seal with the patient's nasal passages in use, aninlet tube 1608 provided to the frame 1602 and adapted to deliverbreathable gas to the patient, and headgear 1605 including a chin strap1606 removably attached to the frame 1602 to maintain the mask 1600 in adesired position on the patient's face.

3.2.0 Improvements/Alternative Arrangements

The following embodiments describe improvements and/or alternativearrangements of Respironics' OptiLife™ mask to enhance respiratorytherapy.

3.2.1 Foam Interface

The OptiLife™ mask includes nasal pillows. In an alternative embodiment,as shown in FIG. 27-2, the nasal pillows may be replaced with a foaminterface F constructed of a foam material F. The foam interface F mayinclude one or more of the foam properties described above, e.g.,visco-elastic, de-skinned, etc.

In such embodiment, the foam interface F may be provided with an adaptorhaving a base that supports the foam interface F and couples the foaminterface F to the existing frame 1602 of the OptiLife™ mask.

3.2.2 Foam Cheek Pads

In another embodiment, as shown in FIG. 27-3, each side strap of theheadgear 1605 may include a foam cheek pad 1607 to improve comfortand/or stability.

3.2.3 Side Inlet Ports

In another embodiment, as shown in FIG. 27-4, the frame 1602 may includeside inlet ports 1614 adapted to engage respective inlet tubes 1608. Forexample, the frame may be structured similar to that provided onRespironics' ComfortCurve™ mask.

3.2.4 Collapsible Inlet Tubes

In another embodiment, as shown in FIG. 27-5, the frame 1602 may includeside inlet ports 1614 adapted to engage collapsible inlet tubes 1640including one or more of the collapsible tube properties describedabove.

In an embodiment, the collapsible inlet tubes 1640 may be routed throughthe headgear 1605, e.g., up towards the top of the patient's head.

3.2.5 Rigidizers

In another embodiment, as shown in FIG. 27-6, a rigidizer 1611 may beprovided one or more straps of the headgear 1605 to improve rigidityand/or stability.

3.2.6 Gap-Filling Structure

In another embodiment, the mask may include structure (e.g., provided tothe headgear, frame, etc.) that is adapted to fill gaps or spacesprovided between the patient's face and the mask/headgear. Thegap-filling structure may improve comfort and/or stability in use. Forexample, as shown in FIG. 27-7, the mask may include structure to fillgaps or spaces S provided between the patient's face and themask/headgear.

3.3 Respironics' ComfortLite™ and ComfortLite™ 2

FIG. 28-1A illustrates a known mask commercially sold by Respironics'under the name of ComfortLite™ and FIG. 28-1B illustrates a known maskcommercially sold by Respironics' under the name of ComfortLite™ 2. Asillustrated, the ComfortLite™ and ComfortLite™ 2 masks 1700 each includea frame 1702, nasal pillows 1704 provided to the frame 1702 and adaptedto form a seal with the patient's nasal passages in use, an inlet tube1708 provided to the frame 1702 and adapted to deliver breathable gas tothe patient, and headgear 1705 to maintain the mask 1700 in a desiredposition on the patient's face.

3.3.0 Improvements/Alternative Arrangements

The following embodiments describe improvements and/or alternativearrangements of Respironics' ComfortLite™ and ComfortLite™ 2 masks toenhance respiratory therapy.

3.3.1 Two Tube Arrangement

In another embodiment, each mask may include two inlet tubes rather thana single inlet tube that extends over the patient's nose to the top ofthe patient's head. For example, as shown in FIGS. 28-2A and 28-2B, theframe 1702 may include side inlet ports 1714 adapted to engagerespective inlet tubes 1708 routed towards the top of the patient'shead.

In such embodiment, one or more portions of the headgear may beeliminated such as the forehead support.

3.4 Fisher & Paykel's Opus™

FIG. 29-1 illustrates another known mask 1800 commercially sold byFisher & Paykel under the name of Opus™. As illustrated, the mask 1800includes a frame 1802, nasal pillows 1804 provided to the frame 1802 andadapted to form a seal with the patient's nasal passages in use, anelbow 1807 provided to the frame 1802 and connected to an inlet tube1808 adapted to deliver breathable gas to the patient, and headgear 1805including a support structure or rigidizer 1809 to maintain the mask1800 in a desired position on the patient's face.

3.4.0 Improvements/Alternative Arrangements

The following embodiments describe improvements and/or alternativearrangements of Fisher & Paykel's Opus™ mask to enhance respiratorytherapy.

3.4.1 Quick Release

The frame 1802, nasal pillows 1804, and elbow 1807 of the Opus™ maskform a sub-assembly that is coupled to the support structure 1809 via aclip arrangement. In an alternative embodiment, quick releasearrangements may be provided to releasably connect the sub-assembly tothe support structure. For example, the sub-assembly may be coupled tothe support structure via a magnet arrangement.

In another embodiment, the sub-assembly may be coupled to the supportstructure in a manner that allows removal of the sub-assembly while theheadgear is maintained on the patient's head.

In another embodiment, the joint between the elbow and the frame can bestructured in a quick-release design, e.g., where the ball joint of theelbow can be resiliently attached/detached from the frame. Thisarrangement allows the frame/nasal pillows to be maintained along withthe headgear on the patient's head.

As shown in FIG. 29-2, the clip arrangement of the Opus™ mask includes aclip 1817 on the bottom portion of the frame 1802 that is adapted toengage a clip receptacle 1819 provided to the support structure 1809. Inan alternative embodiment, as shown in FIG. 29-3, the clip arrangementmay have a reverse position, e.g., clip 1817 provided to a top portionof the frame 1802. This arrangement may allow a more continuous formacross the front of the mask.

In another embodiment, as shown in FIG. 29-4, the clip arrangement maybe arranged to allow the sub-assembly to engage the support structure1809 from the front of the support structure, rather than from the rearof the support structure (e.g. see FIG. 29-2).

In another embodiment, as shown in FIG. 29-5, the support structure mayprovide an annular ring 1821 that is adapted to engage a resilientmating portion or snap-fit connector 1823 provided to the frame 1802.The snap-fit arrangement may be similar to the elbow connectionarrangement of ResMed's VISTA™ mask, e.g., see U.S. Pat. No. 6,907,882which is incorporated herein by reference in its entirety.

In yet another embodiment, as shown in FIG. 29-6, one of the frame 1802and support structure 1809 may include a flange (e.g., flange F on frameas shown in FIG. 29-6) and the other of the frame 1802 and supportstructure 1809 may include a recess (e.g., recess R on support structureas shown in FIG. 29-6) adapted to receive the flange to retain the frameto the support structure.

3.4.2 Adjustment Mechanism

In another embodiment, an adjustment mechanism may be provided to theframe and/or nasal pillows to allow adjustment of the nasal pillows toaccommodate the alar and naso-labial angle of the patient's nose.

3.4.3 Slidable Elbow/Inlet Tube

In another embodiment, the elbow and/or tube may be arranged for slidingmovement relative to the frame to isolate the seal from tube drag. Forexample, FIG. 29-7 illustrates a slidable elbow 1807S that is slidablewith respect to the frame 1802 into multiple operative positions, e.g.,2 or more operative positions.

3.4.4 Low Profile Elbow

In another embodiment, a portion of the elbow may have a substantiallyoval-shaped cross-section (rather than a round cross-section) to providethe elbow with a lower profile.

3.4.5 Tube Routing

In another embodiment, the mask may include two inlet tubes rather thana single inlet tube. For example, as shown in FIG. 29-8 the frame 1802may include side inlet ports 1814 adapted to engage respective inlettubes 1808 routed towards the top of the patient's head.

In such embodiments, the headgear may be eliminated or integrated withthe tubes, e.g., two inlet tubes adapted to deliver breathable gas andstabilize the nasal pillows on the patient's face.

Also, the inlet tubes may be collapsible and may include one or more ofthe collapsible tube properties described above.

3.4.6 Foam Seal

In an alternative embodiment, as shown in FIG. 29-9, the silicone nasalpillows of the Opus™ mask may be replaced with a foam interface 1815constructed of foam F and including one or more of the foam propertiesdescribed above.

In an embodiment, the foam interface may be a block of foam (e.g.,reticulated foam) wherein the perimeter of the interface is sealed orrelatively less permeable and the center of the interface is breathableto act as diffusing mechanism. In such embodiment, the center of theinterface may have two discrete areas for each nostril.

Other foam alternatives include edible packaging foams, fibrous filtermaterial, and foam prongs. The foam prongs may have a bell shape with acylindrical outlet hole, and optional reinforcement may be provided toone or more portions of the foam prongs, e.g., inner walls, outer walls,etc.

In another embodiment, the silicone nasal pillows may be provided with afoam layer on a contact surface adapted to engage the patient's nose.The foam layer may be provided to the nasal pillows in any suitablemanner, e.g., spray-on micro diffuse layer (e.g., HC405). The foam layermay improve comfort, feel, and/or softness, and may provide a moisturewicking feature.

3.5 Puritan Bennett's Breeze® SleepGear® DreamSeal®

FIGS. 30-1 and 30-2 illustrate another known mask 1900 commercially soldby Puritan Bennett under the name of Breeze® SleepGear® DreamSeal®. Asillustrated, the mask 1900 includes a frame 1902, a cushion 1904provided to the frame 1902 and adapted to form a seal with the patient'snose in use, an inlet tube 1908 provided to the frame 1902 and adaptedto deliver breathable gas to the patient, and a head support 1905provided to the frame 1902 to maintain the mask 1900 in a desiredposition on the patient's face.

3.5.0 Improvements/Alternative Arrangements

The following embodiments describe improvements and/or alternativearrangements of Puritan Bennett's Breeze® SleepGear® DreamSeal® mask toenhance respiratory therapy.

3.5.1 Foam Seal

The Breeze® SleepGear® DreamSeal® mask includes a cushion constructed ofa silicone material. In an alternative embodiment, as shown in FIG.30-3, the cushion may be a foam cushion 1904F constructed of a foammaterial F. The foam material F may include one or more of the foamproperties described above, e.g., visco-elastic, un-skinned, etc.

3.5.2 One-Piece Tube/Head Support

The head support 1905 of the Breeze® SleepGear® Dream Seal® maskincludes a metal spring 1911 that supports a cradle 1913 adapted toengage the rear the patient's head (e.g., see FIG. 30-1). In analternative embodiment, the metal spring 1911 may be replaced with aplastic component that may be molded in one-piece with the remainder ofthe head support. In addition, the one-piece head support may beovermolded with the inlet tube 1908, e.g., to reduce the number ofparts, facilitate assembly, etc.

3.5.3 Lower Profile

As shown in FIG. 30-2, the Breeze® SleepGear® DreamSeal® mask includes agap G between the inlet tube 1908 and the nose/forehead of the patient'sface. In an alternative embodiment, the gap G may be reduced by changingthe contour and/or routing of the inlet tube 1908. For example, as shownin FIG. 30-4, the inlet tube 1908 may be flatter towards the top of thepatient's head (e.g., more oval-shaped cross-section 1917 as opposed toround-shaped cross-section 1919) and have a configuration such that itprovides narrower portion 1921 as it passes between the patient's eyes(e.g., hourglass-shaped).

3.5.4 Two Tube Arrangement

In another embodiment, the mask may include two inlet tubes rather thana single inlet tube. For example, as shown in FIG. 30-5, the frame 1902may include side inlet ports 1914 adapted to engage respective inlettubes 1908 routed towards the top of the patient's head.

In such arrangement, a manifold 1916 may be provided at the top of thepatient's head to interconnect the tubes 1908.

3.5.5 Cover or Sock

In another embodiment, one or more portions of the frame, inlet tube,and/or head support may include a cover or sock to improve aestheticsand/or comfort.

3.6 InnoMed Technologies' Nasal-Aire™

FIGS. 31-1 and 31-2 illustrate another known mask 2000 commercially soldby InnoMed Technologies under the name of Nasal-Aire™. As illustrated,the mask 2000 includes a nasal interface 2004 provided to the patient'snose in use, inlet tubes 2008 provided to the respective sides of thenasal interface 2004 to deliver breathable gas to the patient, amanifold 2006 to interconnect the inlet tubes 2008, and a head strap2005 to maintain the mask 2000 in a desired position on the patient'sface.

3.6.0 Improvements/Alternative Arrangements

The following embodiments describe improvements and/or alternativearrangements of InnoMed Technologies' Nasal-Aire™ mask to enhancerespiratory therapy.

3.6.1 Collapsible Tubes

The inlet tubes of the Nasal-Aire™ mask are substantiallynon-collapsible and/or crush-resistant. In an alternative embodiment,the inlet tubes may be replaced with collapsible conduits adapted todeliver breathable gas and stabilize the nasal interface on thepatient's face. The collapsible conduits may include one or more of thecollapsible tube properties described above. For example, each conduitmay be provided with a rigidizer and/or each conduit may have a generalD-shaped cross-section.

3.6.2 Back Strap

In an embodiment, as shown in FIG. 31-3, the mask may include a backstrap 2009 rather than a full head strap to maintain the mask in adesired position on the patient's face. The back strap 209 may includeone or more of the back strap properties described above.

3.6.3 Foam Seal

The Nasal-Aire™ mask includes a nasal interface constructed of asilicone material. In an alternative embodiment, as shown in FIG. 31-4,the nasal interface may be a foam nasal interface 2004F constructed of afoam material F. The foam material F may include one or more of the foamproperties described above, e.g., visco-elastic, un-skinned, etc.

3.6.4 Manifold

The manifold of the Nasal-Aire™ mask includes a relatively rigid,one-piece, plastic structure. In an alternative embodiment, the manifoldmay be constructed of more than one material, e.g., rigid portion andsemi-rigid portion, to improve comfort and/or aesthetics.

In another embodiment, the manifold may be positioned on the patient'shead, rather than hang downwardly from the patient's head.

A preferred interfacing structure according to an embodiment of theinvention utilizes foam having properties as set forth in FIG. 14-1.Known sealing interfaces have quite different bulk properties, forexample, a typical silicone has a density in the range of 1050 to 1150kg/m{circumflex over ( )}3, a tear strength of 20 to 40 N/mm, a tensilestrength of approximately 10 Mpa, an elongation at break of 600%, a 40Shore A hardness, hysteresis of less than about 5%, a resilience ofapproximately 40 to 50%, and an air permeability of 0.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, barriatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike in non-medical applications.

What is claimed is:
 1. A mask system to deliver respiratory therapy to apatient, the mask system comprising: a patient interface that includes anasal cushion portion shaped to seal around both nostrils of the patientand deliver pressurized air from a breathing chamber defined by thepatient interface through a single air delivery orifice to bothnostrils, the single air delivery orifice of the patient interface beingsized to receive both nostrils without the patient interface havingpositively intruding features inside the nostrils, the patient interfacedefining a first passage for introduction of pressurized air into thebreathing chamber at a first lateral side of the patient interface and asecond passage for introduction of pressurized air into the breathingchamber at a second lateral side of the patient interface that opposesthe first lateral side of the patient interface; and a conduit headgearsystem that provides a combined air delivery and stabilizing structurefor the patient interface, the conduit headgear system including: afirst inlet conduit to introduce pressurized air into the breathingchamber of the patient interface through the first passage, the firstinlet conduit structured to engage against a first side of a head of thepatient and pass between a first ear of the patient and a first eye ofthe patient when the mask system is worn by the patient, the first inletconduit being biased open and being structured to transition to acollapsed phase in which conductance of pressurized air through thefirst inlet conduit is reduced to a negligible amount upon the head ofthe patient resting on the first inlet conduit against bedding; a secondinlet conduit to introduce pressurized air into the breathing chamber ofthe patient interface through the second passage, the second inletconduit structured to engage against a second side of the head of thepatient and pass between a second ear of the patient and a second eye ofthe patient when the mask system is worn by the patient, the secondinlet conduit being biased open and being structured to transition to acollapsed phase in which conductance of pressurized air through thesecond inlet conduit is reduced to a negligible amount upon the head ofthe patient resting on the second inlet conduit against bedding; a backstrap to extend across an occiput of the patient when the mask system isworn by the patient, the back strap being attachable with the firstinlet conduit above the first ear of the patient and being attachablewith the second inlet conduit above the second ear of the patient; and amanifold shaped to connect a supply of pressurized air to both the firstinlet conduit and the second inlet conduit while the manifold engagesagainst a top of the head of the patient.
 2. The mask system of claim 1,wherein the back strap is elastic.
 3. The mask system of claim 2,wherein a length of the back strap is adjustable using hook and loopmaterial.
 4. The mask system of claim 1, wherein the mask system lacks aheadgear strap other than the back strap, first inlet conduit, andsecond inlet conduit to maintain the patient interface in a desiredposition on the head of the patient.
 5. The mask system of claim 1,wherein: the first inlet conduit is removably attachable to the patientinterface at a first joint; and the second inlet conduit is removablyattachable to the patient interface at a second joint.
 6. The masksystem of claim 5, wherein: the first inlet conduit and the patientinterface provide no visible step change across the first joint when thefirst inlet conduit is attached to the patient interface; and the secondinlet conduit and the patient interface provide no visible step changeacross the second joint when the second inlet conduit is attached to thepatient interface.
 7. The mask system of claim 1, wherein the nasalcushion portion comprises a cradle for a nose of the patient.
 8. Themask system of claim 7, wherein the patient interface is shaped to sealentirely below a nasal bridge of the patient.
 9. The mask system ofclaim 8, wherein the nasal cushion portion of the patient interfaceincludes a membrane flap and is adapted to seal around the nostrils ofthe patient through deflection of the membrane flap.
 10. The mask systemof claim 9, wherein the nasal cushion portion of the patient interfacecomprises a dual-wall, under-the-nose interface that includes themembrane flap and an undercushion.
 11. The mask system of claim 10,wherein the nasal cushion portion of the patient interface is formed ofsilicone.
 12. The mask system of claim 9, wherein the patient interfaceis shaped to concurrently seal around the nostrils of the patient andaround the mouth of the patient.
 13. The mask system of claim 1, whereinthe mask system is structured so that: the first inlet conduit is spacedapart from the first ear and the first eye when the mask system is wornby the patient; and the second inlet conduit is spaced apart from thesecond ear and the second eye when the mask system is worn by thepatient.
 14. The mask system of claim 1, wherein: the first inletconduit maintains an approximately constant hydraulic diameter along alongitudinal length of the first inlet conduit; and the second inletconduit maintains an approximately constant hydraulic diameter along alongitudinal length of the second inlet conduit.
 15. The mask system ofclaim 14, wherein: the first inlet conduit has a non-cylindricalcross-sectional shape; the second inlet conduit has a non-cylindricalcross-sectional shape; a patient-facing side of the first inlet conduitthat faces the patient when the mask system is worn by the patient isrelatively flat; and a patient-facing side of the second inlet conduitthat faces the patient when the mask system is worn by the patient isrelatively flat.
 16. The mask system of claim 15, wherein: the firstinlet conduit comprises a first elongate molded section that is adaptedto extend across the first side of the head of the patient between thefirst ear and the first eye; the second inlet conduit comprises a secondelongate molded section that is adapted to extend across the second sideof the head of the patient between the second ear and the second eye;the first elongate molded section is molded from silicone; and thesecond elongate molded section is molded from silicone.
 17. The masksystem of claim 16, wherein the first elongate molded section, thesecond elongate molded section, and a base portion of the manifold thatconnects to the first elongate molded section and the second elongatemolded section are integrally formed as a unitary structure.
 18. Themask system of claim 17, wherein the manifold includes means forconnecting to the supply of pressurized air.
 19. The mask system ofclaim 18, wherein: the patient interface includes means for ventingexhaled gases; and the patient interface includes means for connectingto the first inlet conduit and means for connecting to the second inletconduit.
 20. The mask system of claim of claim 14, wherein: the firstinlet conduit has a D-shaped cross-sectional shape; and the second inletconduit has a D-shaped cross-sectional shape.
 21. The mask system ofclaim 1, wherein: a width of the first inlet conduit at a first locationof the first inlet conduit is greater than a width of the first inletconduit at a second location of the first inlet conduit; a height of thefirst inlet conduit at the first location of the first inlet conduit isless than a height of the first inlet conduit at the second location ofthe first inlet conduit; a width of the second inlet conduit at a firstlocation of the second inlet conduit is greater than a width of thesecond inlet conduit at a second location of the second inlet conduit;and a height of the second inlet conduit at the first location of thesecond inlet conduit is less than a height of the second inlet conduitat the second location of the second inlet conduit.
 22. The mask systemof claim 21, wherein: the first inlet conduit has a D-shapedcross-sectional shape at the first location of the first inlet conduitand at the second location of the first inlet conduit; and the secondinlet conduit has a D-shaped cross-sectional shape at the first locationof the second inlet conduit and at the second location of the secondinlet conduit.
 23. The mask system of claim 22, wherein: the first inletconduit tapers in width from the first location of the first inletconduit to the second location of the first inlet conduit; the firstinlet conduit tapers in height from the second location of the firstinlet conduit to the first location of the first inlet conduit; thesecond inlet conduit tapers in width from the first location of thesecond inlet conduit to the second location of the second inlet conduit;and the second inlet conduit tapers in height from the second locationof the second inlet conduit to the first location of the second inletconduit.
 24. The mask system of claim 22, wherein: the first inletconduit is structured so that, in the collapsed phase of the first inletconduit, opposing interior surfaces of a portion of the first inletconduit that has the D-shaped cross-sectional shape contact each other;and the second inlet conduit is structured so that, in the collapsedphase of the second inlet conduit, opposing interior surfaces of aportion of the second inlet conduit that has the D-shapedcross-sectional shape contact each other.
 25. A mask system to deliverrespiratory therapy to a patient, the mask system comprising: a patientinterface that includes a nasal cushion portion shaped to seal aroundboth nostrils of the patient and deliver pressurized air from abreathing chamber defined by the patient interface through a single airdelivery orifice to both nostrils, the single air delivery orifice ofthe patient interface being sized to receive both nostrils without thepatient interface having positively intruding features inside thenostrils, the patient interface defining a first passage forintroduction of pressurized air into the breathing chamber at a firstlateral side of the patient interface and a second passage forintroduction of pressurized air into the breathing chamber at a secondlateral side of the patient interface that opposes the first lateralside of the patient interface; and a conduit headgear system thatprovides a combined air delivery and stabilizing structure for thepatient interface, the conduit headgear system including: a first inletconduit to introduce pressurized air into the breathing chamber of thepatient interface through the first passage, the first inlet conduitstructured to engage against a first side of a head of the patient andpass between a first ear of the patient and a first eye of the patientwhen the mask system is worn by the patient, the first inlet conduitbeing biased open and being structured to transition to a collapsedphase in which conductance of pressurized air through the first inletconduit is reduced to a negligible amount upon the head of the patientresting on the first inlet conduit against bedding, wherein the firstinlet conduit has a D-shaped cross-sectional shape; a second inletconduit to introduce pressurized air into the breathing chamber of thepatient interface through the second passage, the second inlet conduitstructured to engage against a second side of the head of the patientand pass between a second ear of the patient and a second eye of thepatient when the mask system is worn by the patient, the second inletconduit being biased open and being structured to transition to acollapsed phase in which conductance of pressurized air through thesecond inlet conduit is reduced to a negligible amount upon the head ofthe patient resting on the second inlet conduit against bedding, whereinthe second inlet conduit has a D-shaped cross-sectional shape; a backstrap to extend across an occiput of the patient when the mask system isworn by the patient, the back strap being attachable with the firstinlet conduit above the first ear of the patient and being attachablewith the second inlet conduit above the second ear of the patient; and amanifold shaped to connect a supply of pressurized air to both the firstinlet conduit and the second inlet conduit while the manifold engagesagainst a top of the head of the patient, the manifold including a baseportion that is integrally formed as a unitary structure with (i) afirst elongate portion of the first inlet conduit that is shaped to passbetween the first ear and the first eye, and (ii) a second elongateportion of the second inlet conduit that is shaped to pass between thesecond ear and the second eye.
 26. The mask system of claim 25, wherein:the first inlet conduit is structured so that, in the collapsed phase ofthe first inlet conduit, opposing interior surfaces of a portion of thefirst inlet conduit that has the D-shaped cross-sectional shape contacteach other; and the second inlet conduit is structured so that, in thecollapsed phase of the second inlet conduit, opposing interior surfacesof a portion of the second inlet conduit that has the D-shapedcross-sectional shape contact each other.
 27. The mask system of claim25, wherein the mask system lacks a headgear strap other than the backstrap, first inlet conduit, and second inlet conduit to maintain thepatient interface in a desired position on the head of the patient. 28.The mask system of claim 25, wherein: the first inlet conduit maintainsan approximately constant hydraulic diameter along a longitudinal lengthof the first inlet conduit despite a cross-sectional shape of the firstinlet conduit varying along the longitudinal length of the first inletconduit; and the second inlet conduit maintains an approximatelyconstant hydraulic diameter along a longitudinal length of the secondinlet conduit despite a cross-sectional shape of the second inletconduit varying along the longitudinal length of the second inletconduit.
 29. A mask system to deliver respiratory therapy to a patient,the mask system comprising: a patient interface that includes a nasalcushion portion shaped to seal around both nostrils of the patient anddeliver pressurized air from a breathing chamber defined by the patientinterface through a single air delivery orifice to both nostrils, thesingle air delivery orifice of the patient interface being sized toreceive both nostrils without the patient interface having positivelyintruding features inside the nostrils, the patient interface defining afirst passage for introduction of pressurized air into the breathingchamber at a first lateral side of the patient interface and a secondpassage for introduction of pressurized air into the breathing chamberat a second lateral side of the patient interface that opposes the firstlateral side of the patient interface, wherein the nasal cushion portionof the patient interface includes a membrane flap and is adapted to sealaround the nostrils of the patient through deflection of the membraneflap, wherein the patient interface is shaped to seal entirely below anasal bridge of the patient, wherein the patient interface includesmeans for connecting to the first inlet conduit and means for connectingto the second inlet conduit; and a conduit headgear system that providesa combined air delivery and stabilizing structure for the patientinterface, the conduit headgear system including: a first inlet conduitto introduce pressurized air into the breathing chamber of the patientinterface through the first passage, the first inlet conduit structuredto engage against a first side of a head of the patient and pass betweena first ear of the patient and a first eye of the patient when the masksystem is worn by the patient, the first inlet conduit being biased openand being structured to transition to a collapsed phase in whichconductance of gas through the first inlet conduit is reduced tonegligible amounts upon the head of the patient resting on the firstinlet conduit against bedding, wherein the first inlet conduit has aD-shaped cross-sectional shape, wherein the first inlet conduitmaintains an approximately constant hydraulic diameter along alongitudinal length of the first inlet conduit despite a cross-sectionalshape of the first inlet conduit varying along the longitudinal lengthof the first inlet conduit, wherein the first inlet conduit is removablyattachable to the patient interface at a first joint and the first inletconduit and the patient interface provide no visible step change acrossthe first joint when the first inlet conduit is attached to the patientinterface; a second inlet conduit to introduce pressurized air into thebreathing chamber of the patient interface through the second passage,the second inlet conduit structured to engage against a second side ofthe head of the patient and pass between a second ear of the patient anda second eye of the patient when the mask system is worn by the patient,the second inlet conduit being biased open and being structured totransition to a collapsed phase in which conductance of gas through thesecond inlet conduit is reduced to negligible amounts upon the head ofthe patient resting on the second inlet conduit against bedding, whereinthe second inlet conduit has a D-shaped cross-sectional shape, whereinthe second inlet conduit maintains an approximately constant hydraulicdiameter along a longitudinal length of the second inlet conduit despitea cross-sectional shape of the second inlet conduit varying along thelongitudinal length of the second inlet conduit, wherein the secondinlet conduit is removably attachable to the patient interface at asecond joint and the second inlet conduit and the patient interfaceprovide no visible step change across the second joint when the secondinlet conduit is attached to the patient interface; a back strap toextend across an occiput of the patient when the mask system is worn bythe patient, the back strap being attachable with the first inletconduit above the first ear of the patient and being attachable with thesecond inlet conduit above the second ear of the patient, wherein themask system lacks a headgear strap other than the back strap, the firstinlet conduit, and the second inlet conduit to maintain the patientinterface in a desired position on the head of the patient; and amanifold shaped to connect a supply of pressurized air to both the firstinlet conduit and the second inlet conduit while the manifold engagesagainst a top of the head of the patient, the manifold including a baseportion that is integrally formed as a unitary structure with (i) afirst elongate portion of the first inlet conduit that is shaped to passbetween the first ear and the first eye, and (ii) a second elongateportion of the second inlet conduit that is shaped to pass between thesecond ear and the second eye, wherein the manifold includes means forconnecting to the supply of pressurized air.